ClearanceBrief
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

Decided510(k)Device and applicantCode
Feb 17, 1993K925542OXYSHUTTLE II ,MODIFICATION
Sensor Medics Corp.
DQA
Feb 10, 1993K923343HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER
Hewlett-Packard Co., DE
DQA
Jan 7, 1993K920082BIOCHEM MODEL 3301 NEWOX1 OXIMETER
Biochem International, Inc.
DQA
Dec 23, 1992K910811SENSOR SHIELD
Medical Taping Systems, Inc.
DQA
Nov 4, 1992K922075AVOXIMETER
A-Vox Systems, Inc.
DQA
Oct 23, 1992K921519OXICOM-2100
Waters Instruments, Inc.
DQA
Sep 28, 1992K923682MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
Hewlett-Packard Co., DE
DQA
Jul 15, 1992K920379NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX
Novametrix Medical Systems, Inc.
DQA
Jul 14, 1992K914538UPH-2000 UNIVERSAL OXIMETRY PROBE HOLDER
Innovative Medical Products, Inc.
DQA
Jun 24, 1992K915773P-300 CAPNOGRAPH AND PULSE OXIMETER
Pryon Corp.
DQA
Jun 2, 1992K910077CRIT-SCAN
Noninvasive Medical Technology Corp.
DQA
May 1, 1992K914620HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION
Vitalog Monitoring,Inc.
DQA
Feb 26, 1992K913790SENSORMEDICS OXYSHUTTLE II(TM)
Sensor Medics Corp.
DQA
Nov 14, 1991K912880VITALMAX 510/520
Pace Tech, Inc.
DQA
Nov 13, 1991K913695NELLCOR(R) N-180 PULSE OXIMETER
Nellcor, Inc.
DQA
Nov 4, 1991K913516MODEL 520A NOVAMETRIX PULSE OXIMETER
Novametrix Medical Systems, Inc.
DQA
Oct 31, 1991K911761SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION
S & W Medico Teknik, DK
DQA
Oct 30, 1991K913489SIEMENS MICRO2 PULSE OXIMETER
Siemens Medical Electronics
DQA
Oct 23, 1991K913332CIBA CORNING MODEL 270 CO-OXIMETER
Ciba Corning Diagnostics Corp.
DQA
Aug 26, 1991K911207OXICOMPLUS
Waters Instruments, Inc.
DQA
Jul 18, 1991K910001MODEL 8604-FO PULSE OXIMETER
Nonin Medical, Inc.
DQA
Jun 10, 1991K911191PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR
Palco Laboratories, Inc.
DQA
Jun 7, 1991K911124503 PULSE OXIMETER
Criticare Systems, Inc.
DQA
May 28, 1991K905310MINIOX V PULSE OXIMETER
Catalyst Research Corp.
DQA
May 28, 1991K905140SATLITE PLUS PULSE OXIMETER
Datex Division Instrumentarium Corp., FI
DQA
May 14, 1991K910770504US PULSE OXIMETER
Criticare Systems, Inc.
DQA
May 14, 1991K910629AP-860PA NIBP MODULE
Nihon Kohden America, Inc.
DQA
Apr 18, 1991K910521SYSTEM 7300 PULSE OXIMETER
Advanced Medical Instruments, Inc.
DQA
Mar 18, 1991K904988PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR
Palco Laboratories, Inc.
DQA
Feb 5, 1991K904088ARTRAC VITAL SIGNS MON. MODELS 7000 AND 5000 & ACC
Sentinel
DQA
Dec 27, 1990K904039REFLECTANCE SENSOR (RS-10)
Nellcor, Inc.
DQA
Nov 29, 1990K900001COROMETRICS MODEL 556 NEONATAL MONITOR
Ge Medical Systems Information Technologies
DQA
Oct 23, 1990K903523HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE
Hewlett-Packard Co., DE
DQA
Oct 22, 1990K902730SPO2 OPTION
Protocol Systems, Inc.
DQA
Oct 19, 1990K903702MODEL 90421 FLEXPORT INTERFACE
Spacelabs, Inc.
DQA
Sep 27, 1990K902779MODIFICATION TYPE 9266 SA02 SYSTEM ATHENA
S & W Medico Teknik, DK
DQA
Aug 28, 1990K901066VITALMAX 500 PULSE OXIMETER W/TEMP. AND RESPIRA.
Pace Tech, Inc.
DQA
Aug 23, 1990K902758COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC
Cobe Laboratories, Inc.
DQA
Aug 23, 1990K902192MODEL MSC SA02-5000 PULSE OXIMETER
Medical Systems Corp.
DQA
Aug 23, 1990K901504MODELS 706 ECG/PRESSURE/RESP./SAO2, 705 ECG/RESP.
Ivy Biomedical Systems, Inc.
DQA
Aug 14, 1990K900757ITC ANGIOGRAPHIC CATHETER
Interventional Therapeutics Corp.
DQA
Aug 14, 1990K896738TYPE 9293 INTERFACE PULSEOX
S & W Medico Teknik, DK
DQA
Jul 18, 1990K901819MODEL 78834C NEONATAL PULSE OXIMETER (SAO2)
Hewlett-Packard Co., DE
DQA
Jun 19, 1990K901071PULSE OXIMETRY MODULE
Marquette Electronics, Inc.
DQA
Jun 12, 1990K901399POWERBASE II (PB2)
Nellcor, Inc.
DQA
Jun 11, 1990K902060ESCORT MODEL 300
Medical Data Electronics
DQA
May 22, 1990K901774HORIZON 2000 PULSE OXIMETRY (SAO2) MONITOR CAPABIL
Mennen Medical, Inc.
DQA
May 18, 1990K892217CAV SAT OXIMETER MODEL 100
Somanetics Corp.
DQA
May 15, 1990K901060EDENTEC MODEL 2000W SYSTEM 700 MONITOR
Edentec Corp.
DQA
May 9, 1990K894100OXYTRAK(TM) PULSE OXIMETER
Critikon Company, LLC
DQA

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