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Panels › Cardiovascular › Product code DQA · Class 2

Oximeter

Regulation 870.2700

13510(k)s in 12 months (727 all time)
9recalls in 12 months (128 all time)
101recalls that name a 510(k)
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Top companies in DQA

Company510(k)sRecalls
Masimo Corp.7714
Nonin Medical, Inc.423
Oridion Medical 1987 , Ltd.132
Philips Healthcare Inc.025
Nellcor Puritan Bennett, Inc.194
Beijing Choice Electronic Technololgy Co., Ltd.210
Philips Medical Systems85
Covidien102
Dolphin Medical, Inc.120
Bci Intl., Inc.110
Decided510(k)Device and applicantCode
Sep 23, 1987K873078NOVAMETRIX MODEL 505 PULSE OXIMETER
Novametrix Medical Systems, Inc.
DQA
Sep 15, 1987K872626OXIMETRY MODULE
Marquette Electronics, Inc.
DQA
Jun 29, 1987K871826PB VIDEO DISPLAY TO PB251 PULSE OXIMETER UPGRADE
Datex Division Instrumentarium Corp., FI
DQA
Jun 24, 1987K871864PB240 PATIENT MONITOR/PULSE OXIMETER
Puritan Bennett Corp.
DQA
Jun 8, 1987K871353OXIMETER
Radiometer America, Inc.
DQA
May 6, 1987K864730INVIVO PULSE OXIMETER, MODEL 4500
Invivo Research Labs, Inc.
DQA
Mar 20, 1987K870621SATLITE/PB251 PULSE OXIMETER
Datex Division Instrumentarium Corp., FI
DQA
Mar 11, 1987K864279SPACELABS MODEL 90419 PULSE OXIMETER MODULE
Spacelabs, Inc.
DQA
Mar 4, 1987K864613502 OXYGEN SATURATION MONITOR
Criticare Systems, Inc.
DQA
Mar 3, 1987K870163BIOCHEM MICROSPAN 1040 OXIMETER
Biochem International, Inc.
DQA
Jan 7, 1987K863918MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT.
Marquest Medical Products, Inc.
DQA
Jan 6, 1987K863855ACCUSAT
Datascope Corp.
DQA
Dec 22, 1986K862812NELLCOR MVP, MODEL N-1000
Nellcor, Inc.
DQA
Nov 21, 1986K863784NELLCOR N-200 (PULSE OXIMETER)
Nellcor, Inc.
DQA
Nov 7, 1986K863186BIOCHEM CO/OX 1000
Biochem International, Inc.
DQA
Sep 26, 1986K862617SENSORMEDICS OXYSHUTTLE(TM)
Sensor Medics Corp.
DQA
Aug 28, 1986K862798MINIOX 100 PULSE OXIMETER
Catalyst Research Corp.
DQA
Aug 18, 1986K862161OSC-80 OXIMETER
Waters Instruments, Inc.
DQA
Jun 5, 1986K860051MODEL 8604 OXYGEN/PULSE MONITOR
Nonin Medical, Inc.
DQA
May 16, 1986K855027PULSE OXIMETER
Physio-Control Corp.
DQA
Dec 27, 1984K844256NELLCOR PULSE OXIMETER N-10
Nellcor, Inc.
DQA
May 9, 1984K833973MINOLTA SM-32 OXYGEN SATURATION MONIT
Marquest Medical Products, Inc.
DQA
Dec 30, 1983K833826BTI BIOX III OXIMETER CRITICAL CAREUNI
Biox Technology, Inc.
DQA
Nov 1, 1982K822909PULSE OXIMETER MODEL 100
Nellcor, Inc.
DQA
Feb 12, 1982K820110BIOX III
Biox Technology, Inc.
DQA
Jan 8, 1979K781879HEATER, OXIMETER SYSTEM
Oximetrix, Inc.
DQA
Apr 28, 1978K780625UNISTAT OXIMETER
American Optical Corp.
DQA

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