Recorder, Paper Chart
Cardiovascular · 21 CFR 870.2810
Recent MDR events
6 adverse event reports on file
- R50N RECORDERApr 11, 2012MalfunctionDraeger Medical Systems, Inc. (it/m)1220063-2012-00030
- INFINITY R50N RECORDERDec 13, 2011MalfunctionDrager Medical Systems, Inc. (it/m)1220063-2011-00078
- LIFETRACESep 10, 2007Kendall- Ltp925767
- COROMETRICSSep 22, 2000MalfunctionGe Medical Systems/marquetteMW1020004
- RED GRID EKG PAPERFeb 4, 1994MalfunctionHealthwatch TechnologiesMW1000641
- ATHENA MONIITORNov 4, 1992MalfunctionNarco Medical Services, Athena1658
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
87 firms currently registered for this product code
Philips North America Llc
Cambridge, MA, US
Philips North America Llc
ANDOVER, MA, US
Airlife Finland Oy
Helsinki Uusimaa, FI
Philips Medizin Systeme Boeblingen Gmbh
BOEBLINGEN Baden-Wurttemberg, DE
Endonest Medical Systems Llp
PALGHAR Maharashtra, IN
Philips North America Llc
Export, PA, US
Philips North America Llc
Murrysville, PA, US
Philips Electronics Ltd
Mississauga Ontario, CA
Ge Medical Systems (china) Co., Ltd.
WUXI Jiangsu, CN
Becton, Dickinson And Company
Irvine, CA, US
Amphenol Medical Technologies (dongguan) Co., Ltd.
Dongguan Guangdong, CN
Shanghai Lions Industrial Co.,ltd.
SHANGHAI, CN
Ge Medical Systems Information Technologies - Critikon De Mexico S. De R.l. De C.v.
JUAREZ Chihuahua, MX
O&m Halyard, Inc.
Alpharetta, GA, US
Nicolay Gmbh
NAGOLD Baden-Wurttemberg, DE
Advanced Instrumentations, Inc.
Miami, FL, US
Draeger Medical Systems, Inc.
ANDOVER, MA, US
Ge Medical Systems Information Technologies, Inc.
Waukesha, WI, US
Kimball Electronics Poland Sp.z O.o
Tarnowo Podgorne Wielkopolskie, PL
A-m Systems
Sequim, WA, US
Schiller Ag
BAAR Zug, CH
Isd Meditech Sdn. Bhd.
PETALING JAYA Selangor, MY
510(k) clearances
87 clearances for this product code
- Edentec Corp.Aug 29, 1991
K910871 · EDENTEC DIGITAL CHARTER MODEL 3710
- Astro-Med, Inc.Aug 13, 1991
K912929 · DASH IV
- Ge Medical Systems Information TechnologiesJan 11, 1991
K905856 · MODEL 556 MONITOR
- Gri Medical Products, Inc.Jun 22, 1990
K902586 · GRI LASERGRAPH(TM) ECG PAPER
- Honeywell, Inc.Jun 19, 1990
K902230 · COLORADO COLOR IMAGING RECORDER
- Gabriel Medical, Inc.May 9, 1990
K901385 · GABRIEL MEDICAL CLS THERMAL RECORDER
- S & W Medico TeknikJan 26, 1990
K895111 · TYPE 9541 RECORDER, PAPER CHART
- Western GraphtecJan 26, 1990
K894922 · WR3500 AND WR3600 SERIES RECORDERS