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
Jun 5, 2008K081285FINGER PULSE OXIMETER, MODEL 9560
Nonin Medical, Inc.
DQA
May 23, 2008K080255NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER
Nonin Medical, Inc.
DQA
May 12, 2008K080238MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER
Masimo Corporation
DQA
May 5, 2008K073454FINGERTIP PULSE OXIMETER, MODEL CMS-50C
Contec Medical System Co., Ltd., CN
DQA
May 2, 2008K071642MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER
Mediaid, Inc.
DQA
Feb 25, 2008K073036FORE-SIGHT, MC-2000 SERIES
Cas Medical Systems, Inc.
DQA
Feb 8, 2008K073024MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES
Masimo Corporation
DQA
Jan 14, 2008K072825FINGERTIP PULSE OXIMETER, MODEL MD300I
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Jan 8, 2008K072581PM-60 PULSE OXIMETER
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
DQA
Nov 5, 2007K071610MEDIAID PULSE OXIMETER M30 AND M34
Mediaid, Inc.
DQA
Oct 19, 2007K072235PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
DQA
Oct 11, 2007K072295CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE
Oridion Capnography, Inc., IL
DQA
Sep 12, 2007K071672SENTEC DIGITAL MONITORING SYSTEM
Sentec AG
DQA
Aug 13, 2007K070371FINGERTIP PULSE OXIMETER MD300C
Beijing Choice Electronic Technololgy Co., Ltd., CN
DQA
Aug 8, 2007K071415DIGITAL PULSE OXIMETER, MODEL 7500FO
Nonin Medical, Inc.
DQA
Jul 13, 2007K063641PC-60, NON-INVASIVEPULSE OXIMETER
Shenzhen Creative Industry Co., Ltd.
DQA
Jul 12, 2007K071285DIGITAL PULSE OXIMETER, MODEL 7500
Nonin Medical, Inc.
DQA
Jul 9, 2007K070732BCI AUTOCON 3304 DIGITAL PULSE OXIMETER
Smiths Medical Pm, Inc.
DQA
Jun 29, 2007K071024MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
Masimo Corporation
DQA
May 31, 2007K062149SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES
International Business Strategies
DQA
May 25, 2007K070408DURAMAX REUSABLE OXIMETRY SENSOR
Nellcor Puritan Bennett, Inc.
DQA
May 11, 2007K062724ACCUPULSE PULSE OXIMETER
Eagle Medical Equipment Co.
DQA
May 4, 2007K063752LIFESENSE, MODEL LS1-9R
Nonin Medical, Inc.
DQA
May 2, 2007K070193ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES
Envitec-Wismar GmbH
DQA
Apr 27, 2007K063783PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
Philips Medical Systems, Inc.
DQA
Apr 12, 2007K061896MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N
Mediaid, Inc.
DQA
Mar 5, 2007K061706CADWELL EASYNET OXIMETER MODULE
Cadwell Laboratories, Inc.
DQA
Jan 31, 2007K061931SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101
Solaris Medical Technology, Inc.
DQA
Jan 22, 2007K063434TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM
Radiometer Basel AG, CH
DQA
Dec 29, 2006K063140RAINBOW ADHESIVE CO-OXIMETRY SENSORS
Masimo Corporation
DQA
Nov 15, 2006K053420TENACORE SP02 SENSORS
Tenacore Holdings, Inc.
DQA
Nov 9, 2006K062605PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T
Philips Medical Systems
DQA
Nov 3, 2006K062455PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL
Philips Medical Systems
DQA
Oct 25, 2006K062338TELEVISIT
PHD Medical, CA
DQA
Oct 18, 2006K062268MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03
Philips Medical Systems North America Co.
DQA
Sep 29, 2006K052544PULSE OXIMETER ADAPTER CABLES
American I.V. Products, Inc.
DQA
Sep 5, 2006K061442PULSE OXIMETER, MODEL PM-50
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
DQA
Aug 14, 2006K060576NELLCOR OXIMAX N-600X PULSE OXIMETER
Nellcor Puritan Bennett, Inc.
DQA
Jul 27, 2006K061204MASIMO SET RADICAL 7 PULSE CO-OXIMETER
Masimo Corporation
DQA
Jul 17, 2006K060675ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS
Envitec-Wismar GmbH
DQA
Jul 7, 2006K061329INFINITY MASIMO SET SP02 POD
Draeger Medical Systems, Inc.
DQA
Jun 29, 2006K060616NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100
PHD Medical, CA
DQA
Jun 16, 2006K060143LNCS AND SPO2.COM SENSORS
Masimo Corporation
DQA
Jun 15, 2006K060524DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES
Dolphin Medical, Inc.
DQA
Jun 15, 2006K053381WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE
Welch Allyn, Inc.
DQA
May 22, 2006K061191FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2
Measurement Specialties, Inc.
DQA
May 22, 2006K061112CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M
Conmed Corporation
DQA
May 11, 2006K053419KONICA MINOLTA PULSOX-300, 300I
Konica Minolta Sensing, Inc.
DQA
May 4, 2006K060065CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR
Oridion Capnography, Inc., IL
DQA
Apr 20, 2006K060843MODIFICATION TO HEALTH BUDDY APPLIANCE
Health Hero Network, Inc.
DQA

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