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

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
Mar 3, 2010K093757MD300C1 FINGERTIP PULSE OXIMETER
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Jan 8, 2010K092652FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Dec 4, 2009K092620MD300C318 FINGERTIP PULSE OXIMETER
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Dec 3, 2009K092727H100B PULSE OXIMETER
Edan Instruments, Inc., CN
DQA
Nov 16, 2009K092549OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P
Bio Medical Technologies Co., Ltd.
DQA
Nov 6, 2009K091241MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER
Masimo Corporation
DQA
Oct 21, 2009K092101REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES
Nonin Medical, Inc.
DQA
Oct 15, 2009K092838MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8
Masimo Corporation
DQA
Oct 9, 2009K091787MODEL 6000 TWO PARAMETER BEDSIDE MONITOR
Ivy Biomedical Systems, Inc.
DQA
Oct 1, 2009K092678EVISION DATA MANAGEMENT SOFTWARE
Nonin Medical, Inc.
DQA
Sep 22, 2009K091572DISPOSABLE SPO2 SENSOR M1134A
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE
DQA
Sep 3, 2009K092324SPIROPRO
Viasys Healthcare GmbH, DE
DQA
Aug 20, 2009K083448CABLE, TRANSDUCER, MODEL 2400GN
Conmed Corporation
DQA
Aug 10, 2009K090662MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP
Masimo Corporation
DQA
Jul 24, 2009K090438REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR
Envitec-Wismar GmbH
DQA
Jul 20, 2009K090599MD300K1 PULSE OXIMETER
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Jul 9, 2009K091057MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES
Masimo Corporation
DQA
Jul 9, 2009K090165RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20
Masimo Corporation
DQA
Jun 11, 2009K090671PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D
Contec Medical System Co., Ltd., CN
DQA
Jun 10, 2009K083010SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR
Shenzhen Med-Link Electronics Tech Co., Ltd.
DQA
May 14, 2009K083821VITAL SIGNS MONITOR
Edan Instruments, Inc.
DQA
May 4, 2009K090360PHILIPS M3001A MULTI MEASUREMENT SERVER
Philips Medizin Systeme Boblingen GmbH, DE
DQA
May 1, 2009K083557BCI WW1030 PULSE OXIMETER
Smiths Medical Pm, Inc.
DQA
Apr 28, 2009K090205BCI WW1021 PC APPLICATION
Smiths Medical Pm, Inc.
DQA
Apr 24, 2009K083351PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P
Comdek Industrial Corp., TW
DQA
Apr 15, 2009K083787BCI WW1000 PULSE OXIMETER, MODEL WW1000
Smiths Medical Pm, Inc.
DQA
Apr 9, 2009K083705BCI WW1020 PULSE OXIMETER, MODEL WW1020
Smiths Medical Pm, Inc.
DQA
Apr 3, 2009K083466MD2000A VITAL SIGN MONITOR, MODEL MD2000A
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Apr 3, 2009K082846APK SPO2 PULSE OXIMETER SENSOR
APK Technology Co., Ltd., CN
DQA
Apr 2, 2009K083622LNCS OXIMETRY SENSORS
Masimo Corporation
DQA
Mar 19, 2009K083892FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030)
Cas Medical Systems, Inc.
DQA
Mar 9, 2009K083325N-600X WITH SPD, OXIMAX N-600X
Covidien
DQA
Mar 5, 2009K083079QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100
Quanta Computer, Inc.
DQA
Mar 4, 2009K082487M-50 SERIES SPO2 SENSOR
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Feb 6, 2009K082268CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX
Oridion Capnography, Inc., IL
DQA
Jan 15, 2009K081033MIROXI
Mir Medical Intl. Research Srl, IT
DQA
Jan 7, 2009K082789G1B PULSE OXIMETER
General Meditech, Inc., CN
DQA
Dec 2, 2008K082546REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91)
Unimed Medical Supplies, Inc.
DQA
Nov 26, 2008K082888INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997
Draeger Medical Systems, Inc.
DQA
Nov 10, 2008K082641FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL
Contec Medical System Co., Ltd., CN
DQA
Oct 10, 2008K082052MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK
Masimo Corporation
DQA
Oct 9, 2008K080348OXISCAN II DATA MANAGEMENT SYSTEM
Airsep Corp.
DQA
Oct 1, 2008K081572SMARTSIGNS MINPULSE
Huntleigh Healthcare , Ltd., GB
DQA
Sep 24, 2008K081800T12S TELEMETRY TRANSMITTER
Mortara Instrument, Inc.
DQA
Sep 12, 2008K081712FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700
Guangdong Biolight Meditech Co., Ltd., CN
DQA
Sep 9, 2008K081659RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L
Masimo Corporation
DQA
Aug 29, 2008K081937PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE
Philips Medizin Systeme Boeblingen GmbH, DE
DQA
Jul 31, 2008K081870MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO
GE Healthcare Finland Oy
DQA
Jul 25, 2008K073249SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES
Solaris Medical Technology, Inc.
DQA
Jul 2, 2008K081125WRIST PULSE OXIMETER MD300W
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA

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