Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Anesthesiology · 21 CFR 868.1500
Recent MDR events
17 adverse event reports on file
- SAVINAJun 1, 2022MalfunctionDrägerwerk Ag & Co. Kgaa9611500-2022-00128
- PHILIPS M1026B ANESTHETIC GAS MODULEFeb 7, 2020MalfunctionPhilips Medizin Systeme Boeblingen Gmbh3007409280-2020-00040
- PHILIPS M1026B ANESTHETIC GAS ANALYZERDec 3, 2019MalfunctionPhilips Medizin Systeme Boeblingen Gmbh3007409280-2019-00121
- PHILIPS M1026B ANESTHETIC GAS ANALYZERDec 2, 2019MalfunctionPhilips Medizin Systeme Boeblingen Gmbh3007409280-2019-00120
- PHILIPS M1026B ANESTHETIC GAS ANALYZERNov 11, 2019MalfunctionPhilips Medizin Systeme Boeblingen Gmbh3007409280-2019-00089
- PHILIPS M1026B ANESTHETIC GAS MODULEOct 20, 2019MalfunctionPhilips Medizin Systeme Boeblingen Gmbh3007409280-2019-00046
- PHILIPS ANESTHESIA GAS MONITORSep 23, 2019MalfunctionPhilips Medizin Systeme Boeblingen Gmbh3007409280-2019-00020
- A5 ANESTHESIA DELIVERY SYSTEMJan 12, 2015MalfunctionMindray Bio-medical Electronics Co. Ltd.2221819-2014-01123
- S/5 ANESTHESIA MONITOROct 31, 2012MalfunctionGe Healthcare Finland Oy9610105-2012-00041
- S/5 ANESTHESIA MONITOROct 25, 2012MalfunctionGe Healthcare Finland Oy9610105-2012-00040
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
161 firms currently registered for this product code
Ge Medical Systems Information Technologies
EL PASO, TX, US
Ge Medical Systems (china) Co., Ltd.
WUXI Jiangsu, CN
Philips Medizin Systeme Boeblingen Gmbh
BOEBLINGEN Baden-Wurttemberg, DE
Ge Healthcare Finland Oy
HELSINKI Uusimaa, FI
Masimo Corporation
Irvine, CA, US
Raumedic Estonia As
Tallinn Harjumaa, EE
Edan Diagnostics, Inc.
San Diego, CA, US
Philips North America Llc
Export, PA, US
Philips North America Llc
Murrysville, PA, US
Draegerwerk Ag & Co. Kgaa
LUEBECK Schleswig-Holstein, DE
Philips Electronics Ltd
Mississauga Ontario, CA
Industrial Vallera De Mexicali, S. A. De C. V.
Mexicali Mexico, MX
Technical Services For Electronics, Inc.
New Taipei City, TW
Dre Med
Louisville, KY, US
Mindray Ds Usa, Inc.
Mahwah, NJ, US
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
Caf Medical Solutions Inc
Hockley, TX, US
Cbr Enterprise Limited
Hong Kong, HK
Amphenol Medical Technologies (dongguan) Co., Ltd.
Dongguan Guangdong, CN
510(k) clearances
22 clearances for this product code
- Philips Medizin Systeme Boeblingen GmbHApr 29, 2004
K040917 · PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B
- Agilent Technologies, GmbHMay 19, 2000
K994188 · MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5
- Ohmeda MedicalJan 17, 1997
K962648 · OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR
- Ohmeda MedicalOct 19, 1993
K931439 · OHMEDA MODEL 5330 ANESTHETIC MONITOR
- Datascope Corp.Aug 25, 1993
K926451 · DATASCOPE MULTINEX II
- Instrumentarium Corp.Jul 22, 1993
K923433 · AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE
- Datex Division Instrumentarium Corp.Jul 21, 1993
K923276 · CAPNOMAC ULTIMA ANESTHESIA MONITOR
- Datex Division Instrumentarium Corp.Jul 21, 1993
K922876 · AS/3 COP MODULE