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DQA

726 FDA 510(k) clearances · Product code

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RecordFirmDate
NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER (K080255)Nonin Medical, Inc.2008-05-23
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER (K080238)Masimo Corporation2008-05-12
FINGERTIP PULSE OXIMETER, MODEL CMS-50C (K073454)Contec Medical System Co., Ltd.2008-05-05
MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER (K071642)Mediaid, Inc.2008-05-02
FORE-SIGHT, MC-2000 SERIES (K073036)Cas Medical Systems, Inc.2008-02-25
MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES (K073024)Masimo Corporation2008-02-08
FINGERTIP PULSE OXIMETER, MODEL MD300I (K072825)Beijing Choice Electronic Technololgy Co., Ltd.2008-01-14
PM-60 PULSE OXIMETER (K072581)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2008-01-08
MEDIAID PULSE OXIMETER M30 AND M34 (K071610)Mediaid, Inc.2007-11-05
PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR (K072235)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2007-10-19
CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE (K072295)Oridion Capnography, Inc.2007-10-11
SENTEC DIGITAL MONITORING SYSTEM (K071672)Sentec AG2007-09-12
FINGERTIP PULSE OXIMETER MD300C (K070371)Beijing Choice Electronic Technololgy Co., Ltd.2007-08-13
DIGITAL PULSE OXIMETER, MODEL 7500FO (K071415)Nonin Medical, Inc.2007-08-08
PC-60, NON-INVASIVEPULSE OXIMETER (K063641)Shenzhen Creative Industry Co., Ltd.2007-07-13
DIGITAL PULSE OXIMETER, MODEL 7500 (K071285)Nonin Medical, Inc.2007-07-12
BCI AUTOCON 3304 DIGITAL PULSE OXIMETER (K070732)Smiths Medical Pm, Inc.2007-07-09
MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS (K071024)Masimo Corporation2007-06-29
SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES (K062149)International Business Strategies2007-05-31
DURAMAX REUSABLE OXIMETRY SENSOR (K070408)Nellcor Puritan Bennett, Inc.2007-05-25
ACCUPULSE PULSE OXIMETER (K062724)Eagle Medical Equipment Co.2007-05-11
LIFESENSE, MODEL LS1-9R (K063752)Nonin Medical, Inc.2007-05-04
ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES (K070193)Envitec-Wismar GmbH2007-05-02
PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A (K063783)Philips Medical Systems, Inc.2007-04-27
MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N (K061896)Mediaid, Inc.2007-04-12
CADWELL EASYNET OXIMETER MODULE (K061706)Cadwell Laboratories, Inc.2007-03-05
SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101 (K061931)Solaris Medical Technology, Inc.2007-01-31
TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM (K063434)Radiometer Basel AG2007-01-22
RAINBOW ADHESIVE CO-OXIMETRY SENSORS (K063140)Masimo Corporation2006-12-29
TENACORE SP02 SENSORS (K053420)Tenacore Holdings, Inc.2006-11-15
PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T (K062605)Philips Medical Systems2006-11-09
PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL (K062455)Philips Medical Systems2006-11-03
TELEVISIT (K062338)PHD Medical2006-10-25
MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03 (K062268)Philips Medical Systems North America Co.2006-10-18
PULSE OXIMETER ADAPTER CABLES (K052544)American I.V. Products, Inc.2006-09-29
PULSE OXIMETER, MODEL PM-50 (K061442)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-09-05
NELLCOR OXIMAX N-600X PULSE OXIMETER (K060576)Nellcor Puritan Bennett, Inc.2006-08-14
MASIMO SET RADICAL 7 PULSE CO-OXIMETER (K061204)Masimo Corporation2006-07-27
ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS (K060675)Envitec-Wismar GmbH2006-07-17
INFINITY MASIMO SET SP02 POD (K061329)Draeger Medical Systems, Inc.2006-07-07
NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100 (K060616)PHD Medical2006-06-29
LNCS AND SPO2.COM SENSORS (K060143)Masimo Corporation2006-06-16
WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE (K053381)Welch Allyn, Inc.2006-06-15
DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES (K060524)Dolphin Medical, Inc.2006-06-15
CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M (K061112)Conmed Corporation2006-05-22
FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2 (K061191)Measurement Specialties, Inc.2006-05-22
KONICA MINOLTA PULSOX-300, 300I (K053419)Konica Minolta Sensing, Inc.2006-05-11
CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR (K060065)Oridion Capnography, Inc.2006-05-04
MODIFICATION TO HEALTH BUDDY APPLIANCE (K060843)Health Hero Network, Inc.2006-04-20
PM-50 PULSE OXIMETER (K052693)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2006-03-30
MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS (K053477)Masimo Corporation2006-03-16
ONYX II FINGER PULSE OXIMETER, MODEL 9550 (K053130)Nonin Medical, Inc.2006-01-11
OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR (K051271)Nellcor Puritan Bennett, Inc.2006-01-10
THE FINGER GUARD (K052619)T F & G Products2006-01-06
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 (K052669)Nonin Medical, Inc.2005-12-23
ADULT CEREBRAL OXIMETER, MODEL 2040 (K051257)Cas Medical Systems, Inc.2005-12-22
MASIMO SET RAD-8 PULSE OXIMETER (K053269)Masimo Corporation2005-12-21
FOX PULSE OXIMETER (K051736)Shunsuke Nakanishi2005-12-02
PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. (K052377)Philips Medizin Systeme Boeblingen GmbH2005-11-17
NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P (K052186)Nellcor Puritan Bennett, Inc.2005-11-10
WRISTOX MODEL 3100 PULSE OXIMETER (K052829)Nonin Medical, Inc.2005-11-10
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT (K052755)GE Healthcare2005-10-13
OXIMAX NPB-40 HANDHELD PULSE OXIMETER (K051352)Nellcor Puritan Bennett, Inc.2005-08-11
LNOP BLUE OXIMETRY SENSOR (K051439)Masimo Corporation2005-07-15
MODIFICATION TO LNCS OXIMETRY SENSORS (K051212)Masimo Corporation2005-07-12
TESLAOXYSAT, MODEL EFOXYSATE (K050018)Mammendorfer Institute For Physics & Medicine GmbH2005-07-01
750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL (K050844)Cas Medical Systems, Inc.2005-06-23
MODEL 2500A PALMSAT PULSE OXIMETER (K050056)Nonin Medical, Inc.2005-06-21
ONYX II FINGER PULSE OXIMETER, MODEL 9550 (K051107)Nonin Medical, Inc.2005-06-01
AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS (K050252)Masimo Corporation2005-05-11
ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS (K043463)Envitec-Wismar GmbH2005-02-11
LNOPV AD-L AND PD-L OXIMETRY SENSORS (K050068)Masimo Corporation2005-02-09
MASIMO SET RAD 57 PULSE CO-OXIMETER (K042536)Masimo Corporation2005-01-19
4100 PATIENT OXIMETER MODULE (K043359)Nonin Medical, Inc.2005-01-07
DISPOSABLE NON-ADHESIVE SPO2 SENSORS (K042705)Elekon Industries U.S.A., Inc.2004-12-29
PMP4 OXY PRO (K043162)Card Guard Scientific Survival , Ltd.2004-12-29
REUSABLE FINGER CLIP SPO2 SENSORS (K042704)Elekon Industries U.S.A., Inc.2004-11-26
PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A (K042306)Philips Medizin Systeme Boeblingen GmbH2004-10-15
ETG-4000 OPTICAL TOPOGRAPHY SYSTEM (K042501)Hitachi Medical Corp.2004-10-12
LNCS OXIMETRY SENSORS (K042346)Masimo Corporation2004-09-20
MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS (K041964)Mediaid, Inc.2004-09-14
FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS (K041522)Elekon Industries U.S.A., Inc.2004-09-14
PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE (K040178)S.P.O. Medical Equipment, Ltd.2004-09-10
FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE) (K041647)Elekon Industries U.S.A., Inc.2004-09-02
PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 (K032831)Conmed Corporation2004-08-31
DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 (K040380)Dolphin Medical, Inc.2004-08-31
TIDAL WAVE SP MODEL 710/715 AND 715 (K032971)Respironics Novametrix, Inc.2004-08-26
SPOT CHECK PULSE OXIMETER,512/513 (K032949)Respironics Novametrix, Inc.2004-08-23
FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) (K041644)Elekon Industries U.S.A., Inc.2004-07-29
LNCS OXIMETRY SENSORS (K041815)Masimo Corp.2004-07-29
THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT (K041674)Philips Medical Systems2004-07-19
NC SP02 ADAPTER CABLE (K041204)Masimo Corp.2004-06-29
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 (K041156)Nonin Medical, Inc.2004-06-09
MODIFICATION TO AVANT 9600 PULSE OXIMETER (K040589)Nonin Medical, Inc.2004-06-03
MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM (K040581)Vitel Net2004-05-27
MODEL 509M PULSE OXIMETER, MODEL 509M (K032755)Respironics Novametrix, Inc.2004-05-21
NVISION DATA MANAGEMENT SOFTWARE (K033307)Nonin Medical, Inc.2004-05-06
MASIMO SET INTELLIVUE PULSE OXIMETER MODULE (K040259)Masimo Corp.2004-04-22
MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V (K033998)Masimo Corp.2004-03-19
DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 (K033876)Dolphin Medical, Inc.2004-03-11
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