510(k) clearances for Gas-machine, Anesthesia

189 on file

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Jun 25, 2026
K253330 · A5 Anesthesia System (A5); A7 Anesthesia System (A7)
Drägerwerk AG Co. KgaaMay 21, 2026
K252746 · Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)
Codonics.IncorporatedJul 11, 2025
K251352 · Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)
Drägerwerk AG Co. KgaaJul 23, 2023
K230931 · Atlan
Datex-Ohmeda, Inc.Mar 28, 2023
K213867 · Carestation 750/750c
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Mar 26, 2021
K201957 · A8, A9 Anesthesia System
Maquet Critical Care ABMar 18, 2020
K191027 · Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Jan 12, 2018
K171311 · A5 Anesthesia System
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Jan 12, 2018
K171292 · A7 Anesthesia System
Datex-Ohmeda, Inc.Nov 3, 2017
K172045 · Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
Datex-Ohmeda, Inc.Aug 15, 2017
K170872 · Aisys CS2
Maquet Critical Care ABMar 29, 2017
K160665 · FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
Datex-Ohmeda, Inc.Jan 21, 2016
K151570 · Carestation 620/650/650C
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Oct 27, 2015
K151954 · A7 Anesthesia System
Datex-Ohmeda, Inc.Apr 24, 2015
K143530 · Aespire View
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Jan 23, 2015
K142552 · A7 Anesthesia System
Thornhill Research, Inc.Jan 5, 2015
K140264 · MADM
Dre Medical, Inc.Jul 1, 2014
K132903 · DRE VENTURA
Draeger Medical GmbHJun 20, 2014
K133886 · PERSEUS A500
Oricare, Inc.May 9, 2014
K131790 · A9800 ANESTHESIA WORKSTATION
Maquet Critical Care ABMar 20, 2014
K133958 · FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
Datex-Ohmeda, Inc.Dec 20, 2013
K132530 · GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
Datex-OhmedaAug 8, 2013
K131945 · GE DATEX-OHMEDA AVANCE CS2
Philips Anesthesia CareAug 2, 2013
K122063 · INTELLISAVE AX700 ANESTHESIA SYSTEM
Datascope Corp., Patient Monitoring DivisionFeb 14, 2013
K123211 · A5 ANESTHESIA DELIVERY SYSTEM
Datex-Ohmeda, Inc.Feb 6, 2013
K123125 · GE DATEX-OHMEDA AVANCE CS2
Datex-OhmedaOct 12, 2012
K122445 · AESPIRE 7900, AESPIRE VIEW
Mckesson Technologies, Inc.Apr 20, 2012
K113633 · MCKESSON ANESTHESIA CARE
Draeger Medical GmbHMar 28, 2012
K103035 · SMARTPILOT VIEW MODEL MK04500
Advanced Instrumentations, Inc.Jan 26, 2012
K120075 · AM-6000 ANESTHESIA MACHINE
Maquet Critical Care ABJan 13, 2012
K112114 · MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40
Datex-Ohmeda, Inc.Dec 16, 2011
K112722 · GE DATEX-OHMEDA AVANCE
Datex-Ohmeda, Inc.Jul 20, 2011
K110213 · GE DATEX-OHMEDA AISYS
GE Healthcare Finland OyJun 10, 2011
K102389 · NAVIGATOR APPLICATIONS SUITE
Maquet Critical Care ABMay 9, 2011
K102182 · MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30
Mindray DS USA, Inc.Feb 11, 2011
K102471 · AS3700 ANESTHSIA DELIVERY SYSTEM
Codonics, Inc.Feb 7, 2011
K101439 · CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P
Datex-Ohmeda Inc., A Division of Instrumentarium CJan 12, 2010
K092864 · AESPIRE 7900, AESPIRE VIEW
GE Healthcare Finland OyApr 30, 2009
K090892 · GE DATEX-OHMEDA S/5 ADU CARESTATION
GE Healthcare Finland OyApr 1, 2009
K083098 · NAVIGATOR APPLICATIONS SUITE
Datex-Ohmeda, Inc.Mar 5, 2009
K090233 · GE DATEX-OHMEDA AISYS
Philips Medical SystemsDec 18, 2008
K083413 · COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
Draeger Medical AG & Co. KGOct 8, 2008
K081447 · FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO
Datex-Ohmeda, Inc.Aug 29, 2008
K081844 · GE DATEX-OHMEDA AVANCE
GE Healthcare Finland OyAug 7, 2008
K081941 · NAVIGATOR APPLICATIONS SUITE
Draeger Medical AG & Co. KGJul 30, 2008
K072884 · FABIUS MRI
Datascope Corp., Patient Monitoring DivisionJun 9, 2008
K080175 · NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
Datex-Ohmeda, Inc.Jan 30, 2008
K073707 · GE DATEX-OHMEDA AISYS
Oceanic Medical Products, Inc.Jan 22, 2008
K072420 · MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
GE Healthcare Finland OyOct 10, 2007
K071097 · NAVIGATOR APPLICATIONS SUITE
Datex-OhmedaJun 6, 2007
K071142 · GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
DocusysFeb 22, 2007
K062388 · ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
Porter Instrument Co., Inc.Nov 9, 2006
K062155 · DIGITAL MXR-D FLOWMETER
Penlon , Ltd.Jul 28, 2006
K061102 · PRIMA ANAESTHESIA MACHINE
Datex-Ohmeda, Inc.Jun 27, 2006
K061609 · GE DATEX-OHMEDA AISYS
Oceanic Medical Products, Inc.Apr 10, 2006
K060193 · MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2
Accutron, Inc.Nov 23, 2005
K052335 · ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA
Safer Sleep, LLCNov 4, 2005
K050883 · SAFERSLEEP SYSTEM
Blease USA, Inc.Sep 23, 2005
K051629 · BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000
Datex-Ohmeda, Inc.Apr 12, 2005
K050676 · GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU)
Datex-Ohmeda, Inc.Mar 25, 2005
K050626 · GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM
Datex-Ohmeda, Inc.Feb 4, 2005
K050055 · GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
Draeger Medical, Inc.Nov 26, 2004
K042607 · PRIMUS US
Draeger Medical, Inc.Oct 8, 2004
K042419 · FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
Blease Medical Equipment , Ltd.Oct 7, 2004
K041430 · BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000
Mallard Medical, Inc.Sep 3, 2004
K033026 · MALLARD MODEL 3000 ANESTHESIA MACHINE
Draeger Medical, Inc.Aug 31, 2004
K042086 · FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
Datex-Ohmeda, Inc.Aug 31, 2004
K042154 · GE DATEX-OHMEDA AISYS CARESTATION
Draeger Medical, Inc.Jul 8, 2004
K041622 · MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM; FABIUS TIRO ANESTHESIA SYSTEM
Draeger Medical, Inc.Apr 26, 2004
K033498 · NARKOMED 6400, MODEL NM6400
Datex-Ohmeda, Inc.Apr 22, 2004
K040743 · MODIFICATION TO DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
Draeger Medical, Inc.Mar 17, 2004
K030624 · MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
Datex-OhmedaMar 10, 2004
K032803 · DATEX-OHMEDA S/5 AVANCE ANESTHESIA SYSTEM
Philips Medical SystemsJul 15, 2003
K030939 · PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE
Draeger Medical, Inc.Jul 15, 2003
K031400 · FABIUS TIRO ANESTHESIA SYSTEM
Draeger Medical, Inc.Aug 29, 2002
K022031 · NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
Draeger Medical, Inc.Feb 22, 2002
K011404 · FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
Oceanic Medical Products, Inc.Oct 12, 2001
K010613 · MAGELLAN-2200, MODEL 1
Charles A. SmithOct 3, 2001
K012446 · OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
Spacelabs Medical, Inc.Jun 28, 2001
K003663 · SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE
Blease Medical Equipment , Ltd.May 23, 2001
K003251 · BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
Heyer America, Inc.Feb 5, 2001
K001988 · MODULAR
Draeger Medical, Inc.Jan 22, 2001
K003579 · NARKOMED MRI-2, MODEL NM-MRI-2
Heyer America, Inc.Oct 11, 2000
K000995 · NARKOMAT, MODEL 2000
Charles A. SmithAug 23, 2000
K000859 · OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1
Blease Medical Equipment , Ltd.Aug 9, 2000
K001727 · MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES
Draeger Medical, Inc.Jun 9, 2000
K001488 · NARKOMED MRI , NM-MRI
Siemens Elema ABMay 26, 2000
K001315 · MODIFICATION TO KION ANESTHESIA SYSTEM
Datex-Ohmeda, Inc.May 11, 2000
K000706 · DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
Datex-Ohmeda, Inc.Apr 25, 2000
K993410 · DATES-OHMEDA AESTIVA SMARTVENT MRI
Accutron, Inc.Oct 27, 1999
K992421 · GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076
Siemens Medical Solutions USA, Inc.Sep 13, 1999
K973971 · KION ANESTHESIA SYSTEM
Blease Medical Equipment , Ltd.Apr 9, 1999
K982137 · BLEASE FRONTLINE GENIUS RANGE ANAESTHESIA MACHINE
Draeger Medical, Inc.Jan 11, 1999
K983635 · JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
Spacelabs Medical, Inc.Nov 20, 1998
K981530 · SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM
Medical Industrial EquipmentNov 3, 1998
K981845 · HAWK ANAESTHESIA INDUCTION UNIT
Datex-Engstrom, Inc.Oct 30, 1998
K973985 · AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
Draeger Medical, Inc.Aug 4, 1998
K980553 · NARKOMED 6000 MODEL NUMBER NM6000
Ohmeda MedicalApr 21, 1998
K973896 · OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
Draeger Medical, Inc.Feb 6, 1998
K973949 · PERIOPERATIVE DATA MANAGEMENT SYSTEM
Draeger Medical, Inc.Jan 28, 1998
K974193 · NARKOMED ULTRASONIC FLOW SENSOR
Technical Medical Products, Inc.Dec 10, 1997
K970163 · ALPHA MX (20)/ULTRA PC (30)
Medical and Industrial EquipmentNov 12, 1997
K971030 · MIE FALCON, DATEX ENGSTROM FLEXIMA II
Draeger Medical, Inc.Oct 30, 1997
K972848 · NARKOMED MRI ANESTHESIA SYSTEM
Hewlett-Packard GmbHSep 11, 1997
K965160 · HP ORVUE INTRA-OP (M2510A)
Draeger Medical, Inc.Sep 10, 1997
K971425 · NARKOMED M ANESTHESIA SYSTEM (M)
Heyer America, Inc.Aug 11, 1997
K963481 · ANODYNE CC
Ohmeda MedicalJun 17, 1997
K965041 · OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM
Draeger Medical, Inc.Mar 19, 1997
K963994 · NARKOMED GS ANESTHESIA SYSTEM
Ohmeda MedicalOct 8, 1996
K946127 · OHMEDA EXCEL DRAW-OVER MILITARY VAPORIZER SYSTEM
Draeger Medical, Inc.Feb 3, 1995
K945463 · PENDANT MOUNT NARKOMED 2C ANESTHESIUA SYSTEM
Datex Division Instrumentarium Corp.Jan 27, 1995
K945234 · AS/3 MEMORY MODULE, M0MEM
Matrx Medical, Inc.Dec 29, 1994
K945722 · MATRX MDM, RA
Datex Division Instrumentarium Corp.Nov 14, 1994
K933285 · DATEX AS/3 TM ANAESTHESIA MONITOR
Datex Division Instrumentarium Corp.Aug 9, 1994
K923172 · ANAESTHESIA RECORD KEEPER
Vital Signs, Inc.Jun 13, 1994
K935546 · MAC/IV SEDATION KIT
Medelec , Ltd.Apr 26, 1994
K934669 · ARC
Draeger Medical, Inc.Jun 22, 1993
K930351 · NARKOMED 2C ANESTHESIA SYSTEM
Premier Anesthesia SystemsJun 18, 1993
K930492 · IDACARE ANESTHESIA MANAGEMENT WORKSTATIN
Ohmeda Anesthesia Systems Therapy GroupJun 2, 1993
K925580 · OHMEDA TEC 6 (CFV) CONTINUOUS FLOW VAPORIZER, NAD
Ohmeda MedicalMay 26, 1993
K921742 · OHMEDA AUTOCLAVABLE BELLOWS ASSEMBLY
Ohmeda Anesthesia Systems Therapy GroupApr 8, 1993
K913791 · OHMEDA 7800 ANESTHESIA VENTILATOR
HospitronicDec 8, 1992
K923519 · SENSOR GUI
Trek Medical Products, Inc.May 29, 1992
K920944 · FTS-200 GAS SYSTEM
Ohmeda MedicalMay 3, 1991
K905635 · OHMEDA MODULUS CD ANESTHESIA SYSTEM
Siemens Life Support SystemsFeb 25, 1991
K903991 · PCM ANESTHESIA
Shasta Logic Corp.Jan 14, 1991
K903135 · CLINI-CALC
Ohmeda MedicalSep 7, 1990
K901117 · OHMEDA UNIVERSAL PAC
Modular Instruments, Inc.Sep 4, 1990
K902962 · LIFELOG(TM)
Draeger Medical, Inc.Jul 9, 1990
K901713 · NARKOMED 4 ANESTHESIA SYSTEM
Ohmeda MedicalMay 18, 1990
K901119 · OHMEDA MODULUS CD ANESTHESIA SYSTEM
Ohmeda MedicalApr 19, 1990
K893780 · OHMEDA EXCEL MRI COMPATIBLE ANESTHESIA SYSTEM
Draeger Medical, Inc.Apr 5, 1990
K900937 · O.R. DATA MANAGER
Draeger Medical, Inc.Feb 1, 1990
K900328 · NARKOMED 2B ANESTHESIA SYSTEM
Draeger Medical, Inc.Feb 1, 1990
K900329 · NARKOMED 3 ANESTHESIA SYSTEM
Ohmeda MedicalOct 6, 1989
K894309 · OHMEDA MODULUS CD ANESTHESIA SYSTEM
Dentsply Intl.Aug 1, 1989
K884802 · CAVENDISH 460/680 ANESTHESIA MACHINE
Datex Division Instrumentarium Corp.Jun 6, 1989
K884991 · CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN
Ohmeda MedicalApr 12, 1989
K890410 · REVISED OHMEDA MODULUS II ANESTHESIA GAS MACHINE
Matrix Medica, Inc.Feb 9, 1989
K884879 · CENTURION(TM) MIXER
Ohmeda MedicalJul 8, 1988
K882489 · REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS
Ohmeda MedicalMar 24, 1988
K875350 · OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM
Diatek, Inc.Jan 27, 1988
K872178 · MODIFICATION TO ARKIVE(TM)
Bear Medical Systems, Inc.Jun 5, 1987
K864589 · TRI-SERVICE OMV VAPORIZER
Bear Medical Systems, Inc.May 4, 1987
K864590 · AM1000
American Anesthesia, Inc.Mar 9, 1987
K864644 · PHOENIX-C ANESTHESIA MACHINE
Draeger Medical, Inc.Jan 27, 1987
K864447 · NARKOMED 2B ANESTHESIA SYSTEM
Draeger Medical, Inc.Jan 15, 1987
K864806 · ANESTHESIA RECORDER
Diatek, Inc.Jan 12, 1987
K862085 · ARKIVE (TM)
Ohmeda MedicalOct 30, 1986
K863207 · OHMEDA 'B' SERIES GAS DELIVERY SYSTEM
Ohmeda MedicalAug 20, 1986
K862831 · MODIFIED OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
Draeger Medical, Inc.Apr 1, 1986
K861170 · NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED)
Computerized Anesthesia Systems, Inc.Feb 28, 1986
K855022 · COMPUTERIZED ANESTHESIA RECORDING & INFO NETWORK
Draeger Medical, Inc.Jan 22, 1986
K853435 · NARKOMED 3 ANESTHESIA SYSTEM
Agilent Technologies, Inc.Dec 19, 1985
K854213 · ARI STANDARD ANESTHESIA RECORD
Patient Data SystemsSep 6, 1985
K852175 · PATIENT DATA SYSTEMS CVA
American Anesthesia, Inc.Aug 26, 1985
K853139 · PHOENIX ANESTHESIA MACHINE
Ohmeda MedicalJul 1, 1985
K850648 · OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
American Anesthesia, Inc.Jun 14, 1985
K844563 · PHOENIX ANESTHESIA MACHINE
Ohmeda MedicalMay 15, 1985
K844849 · OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA
Draeger Medical, Inc.May 10, 1985
K851621 · BOOM ARM
Penlon, Inc.Mar 12, 1985
K844008 · PENLON AM1000 ANAESTHESIA MACHINE
Puritan Bennett Corp.Jan 14, 1985
K844421 · FOREGGER DOME VALVES
Ohmeda MedicalOct 18, 1984
K844012 · OHMEDA ANESTHESIA RECORD KEEPER
Medimex, Inc.Jun 7, 1984
K841370 · KMA-1300F
Ohio Medical ProductsApr 20, 1984
K840356 · OHIO UNITROL II ANESTHESIA GAS MACHINE
Ohio Medical ProductsApr 13, 1984
K841274 · BAG-TO-VENTILATOR SELECTOR VALVE
Draeger Medical, Inc.Dec 16, 1983
K833147 · CENTRALERT
Fraser Harlake, Inc.Nov 14, 1983
K833151 · BOYLE SYSTEM ANESTHESIA GAS MACHINE
Ohio Medical ProductsNov 14, 1983
K833335 · MODULUS II ANESTHESIA GAS MACHINE
Narco ScientificApr 8, 1983
K830680 · AIR-SHIELDS VENTIMETER VENTILATOR-CONTR
W.E. Leder Enterprises, Inc.Mar 9, 1983
K830159 · ANESTHESIA APPARATUS PH-35
W.E. Leder Enterprises, Inc.Mar 9, 1983
K830161 · ANESTHESIA APATATUS #D-25
W.E. Leder Enterprises, Inc.Mar 9, 1983
K830160 · ANESTHESIA APPARATUS #FO 20S
Draeger Medical, Inc.Sep 7, 1982
K822218 · NARKOMED 2A ANESTHESIA MACHINE
Penlon, Inc.Jan 7, 1981
K803052 · NUFFIELD ANESTHESIA VENTILATOR SER. 400
G. Dundas Co.Nov 12, 1980
K802591 · MODEL 5460 + 5480 POP-OFF VALVES
Narco Mckesson Co.Jun 17, 1980
K801102 · COMPALOR-ORAL SURGERY MODEL
Spica, Inc.May 28, 1980
K800801 · ANALGESIA UNITS, OXYGEN & NITRATE DEVICE
Narco Mckesson Co.May 28, 1980
K801100 · ANALOR FOUR-DENTAL MODEL
Narco Mckesson Co.May 28, 1980
K801103 · COMPALOR-DENTAL MODEL
Ohio Medical ProductsSep 19, 1979
K791530 · OHIO MODULAR ANESTHESIA GAS MACHINE
Narco Mckesson Co.Mar 23, 1979
K790456 · SERIES 7000
Narco Mckesson Co.Sep 11, 1978
K781492 · SERIES 7000 GAS MACHINE
Draeger Medical, Inc.Nov 15, 1977
K771989 · CONTINUOUS FLOW ANESTHESIA MACHINE
Ohio Medical ProductsNov 7, 1977
K771479 · NITROX 30 - ANESTHETIC GAS PROPORTIONER
ForeggerJul 5, 1977
K771057 · ANESTHESIA MACHINE
Draeger Medical, Inc.Mar 30, 1977
K770554 · NARKOMED ANESTHESIA MACHINE
Chemetron Health SystemsAug 6, 1976
K760228 · ANESTHESIA MACHINE, CHEMETRON