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726 FDA 510(k) clearances · Product code

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RecordFirmDate
E1 EAR SENSORS (K121912)Masimo Corporation2012-07-24
NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM (K120773)Covidien, LLC2012-07-10
PULSE OXIMETER (K112843)Nonin Medical, Inc.2012-04-19
PULTOL (K113865)Sharp Corporation2012-03-21
MASIMO SET REUSABLE OXIMETRY SENSORS (K113596)Masimo Corporation2012-02-24
FINGERTIP PULSE OXIMETER (K112804)Guangdong Biolight Meditech Co., Ltd.2012-01-27
HANDHELD PULSE OXIMETER (K111494)Beijing Choice Electronic Technololgy Co., Ltd.2012-01-18
MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES (K111403)Masimo Corporation2011-12-30
PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 (K111617)Acare Technology Co., Ltd.2011-12-22
VTRUST FINGER TYPE PULSE OXIMETER (K110893)Taidoc Technology Corporation2011-11-22
MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS (K111621)Masimo Corporation2011-10-26
MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS (K111888)Masimo Corporation2011-09-23
VITAL SIGNS MONITOR (K112465)Advanced Instruments, Inc.2011-09-14
TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR (K103802)GE Healthcare Finland Oy2011-08-02
DIXTAL DZ-4100 SERIES PULSE OXIMETER (K103285)Dixtal Medical, Inc.2011-07-25
PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA (K103685)Beijing Rongrui-Century Scie. & Tech. Co., Ltd.2011-07-15
ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS (K103584)Shenzhen Envisen Industry Co. Limited2011-06-10
MASIMO RADICAL Y PULSE CO-OXIMETER (K110028)Masimo Corporation2011-03-17
ESSENTIAL MRI PATIENT MONITOR (K103700)Invivo Corporation2011-03-15
ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN (K102270)Envitec-Wismar GmbH2011-02-22
PULSE OXIMETER MODEL P10 (K100225)Mediana Co., Ltd.2011-02-09
CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD (K101995)Oridion Capnography, Inc.2011-01-11
VITAL SIGNS MONITOR (K102835)Edan Instruments, Inc.2010-12-27
PULSE OXIMETER (K102350)Nonin Medical, Inc.2010-12-22
V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201 (K101012)Taidoc Technology Corporation2010-12-15
MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES (K101577)Beijing Choice Electronic Technololgy Co., Ltd.2010-12-02
VITAL SIGNS MONITOR MODEL M3B (K101539)Edan Instruments, Inc.2010-11-24
MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 (K101031)Masimo Corporation2010-11-18
CHARMCARE TABLETOP PULSE OXIMETER (K092641)Charmcare Co., Ltd.2010-10-21
MASIMO LNCS/M-LNCS OXIMETRY SENSORS (K101896)Masimo Corporation2010-10-21
NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 (K100077)Solaris Medical Technology, Inc.2010-10-07
TRUSIGNAL SPO2 FINGERTIP SENSOR (K101871)GE Healthcare Finland Oy2010-10-04
MODEL SB100II FINGER PULSE OXIMETER (K101568)Atlantean2010-09-20
E.S.O. (ELECTRO SENSOR OXI) (K102442)Ld Technology, LLC2010-09-10
HANDHELD PULSE OXIMETER MODEL M800 (K101694)Guangdong Biolight Meditech Co., Ltd.2010-09-08
INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL (K101600)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2010-08-31
MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER (K100428)Masimo Corporation2010-07-09
MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7 (K100403)Masimo Corporation2010-06-23
OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 (K100815)Oxypulse2010-06-16
SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES (K093853)Nonin Medical, Inc.2010-06-04
MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D (K100617)Masimo Corporation2010-05-28
HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M (K100203)Beijing Choice Electronic Technololgy Co., Ltd.2010-05-17
LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS (K094046)Masimo Corporation2010-05-14
VITAL SIGNS MONITOR (K093016)Shenzhen Creative Industry Co., Ltd.2010-03-30
NBM-200MP PULSE OXIMETRY DEVICE (K091564)Orsense, Ltd.2010-03-19
TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR (K093881)GE Healthcare Finland Oy2010-03-12
SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES (K092950)Solaris Medical Technology, Inc.2010-03-12
DX SERIES FINGER SENSOR (K100020)Dixtal Medical, Inc.2010-03-08
SINGLE-PATIENT USE DISPOSABLE SENSOR (K093306)Nonin Medical, Inc.2010-03-04
MD300C1 FINGERTIP PULSE OXIMETER (K093757)Beijing Choice Electronic Technololgy Co., Ltd.2010-03-03
FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA (K092652)Beijing Choice Electronic Technololgy Co., Ltd.2010-01-08
MD300C318 FINGERTIP PULSE OXIMETER (K092620)Beijing Choice Electronic Technololgy Co., Ltd.2009-12-04
H100B PULSE OXIMETER (K092727)Edan Instruments, Inc.2009-12-03
OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P (K092549)Bio Medical Technologies Co., Ltd.2009-11-16
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER (K091241)Masimo Corporation2009-11-06
REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES (K092101)Nonin Medical, Inc.2009-10-21
MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 (K092838)Masimo Corporation2009-10-15
MODEL 6000 TWO PARAMETER BEDSIDE MONITOR (K091787)Ivy Biomedical Systems, Inc.2009-10-09
EVISION DATA MANAGEMENT SOFTWARE (K092678)Nonin Medical, Inc.2009-10-01
DISPOSABLE SPO2 SENSOR M1134A (K091572)Philips Medizinsysteme Boeblingen GmbH, Cardiac AN2009-09-22
SPIROPRO (K092324)Viasys Healthcare GmbH2009-09-03
CABLE, TRANSDUCER, MODEL 2400GN (K083448)Conmed Corporation2009-08-20
MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP (K090662)Masimo Corporation2009-08-10
REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR (K090438)Envitec-Wismar GmbH2009-07-24
MD300K1 PULSE OXIMETER (K090599)Beijing Choice Electronic Technololgy Co., Ltd.2009-07-20
MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES (K091057)Masimo Corporation2009-07-09
RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 (K090165)Masimo Corporation2009-07-09
PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D (K090671)Contec Medical System Co., Ltd.2009-06-11
SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR (K083010)Shenzhen Med-Link Electronics Tech Co., Ltd.2009-06-10
VITAL SIGNS MONITOR (K083821)Edan Instruments, Inc.2009-05-14
PHILIPS M3001A MULTI MEASUREMENT SERVER (K090360)Philips Medizin Systeme Boblingen GmbH2009-05-04
BCI WW1030 PULSE OXIMETER (K083557)Smiths Medical Pm, Inc.2009-05-01
BCI WW1021 PC APPLICATION (K090205)Smiths Medical Pm, Inc.2009-04-28
PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P (K083351)Comdek Industrial Corp.2009-04-24
BCI WW1000 PULSE OXIMETER, MODEL WW1000 (K083787)Smiths Medical Pm, Inc.2009-04-15
BCI WW1020 PULSE OXIMETER, MODEL WW1020 (K083705)Smiths Medical Pm, Inc.2009-04-09
MD2000A VITAL SIGN MONITOR, MODEL MD2000A (K083466)Beijing Choice Electronic Technololgy Co., Ltd.2009-04-03
APK SPO2 PULSE OXIMETER SENSOR (K082846)APK Technology Co., Ltd.2009-04-03
LNCS OXIMETRY SENSORS (K083622)Masimo Corporation2009-04-02
FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030) (K083892)Cas Medical Systems, Inc.2009-03-19
N-600X WITH SPD, OXIMAX N-600X (K083325)Covidien2009-03-09
QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 (K083079)Quanta Computer, Inc.2009-03-05
M-50 SERIES SPO2 SENSOR (K082487)Beijing Choice Electronic Technololgy Co., Ltd.2009-03-04
CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX (K082268)Oridion Capnography, Inc.2009-02-06
MIROXI (K081033)Mir Medical Intl. Research Srl2009-01-15
G1B PULSE OXIMETER (K082789)General Meditech, Inc.2009-01-07
REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91) (K082546)Unimed Medical Supplies, Inc.2008-12-02
INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 (K082888)Draeger Medical Systems, Inc.2008-11-26
FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL (K082641)Contec Medical System Co., Ltd.2008-11-10
MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK (K082052)Masimo Corporation2008-10-10
OXISCAN II DATA MANAGEMENT SYSTEM (K080348)Airsep Corp.2008-10-09
SMARTSIGNS MINPULSE (K081572)Huntleigh Healthcare , Ltd.2008-10-01
T12S TELEMETRY TRANSMITTER (K081800)Mortara Instrument, Inc.2008-09-24
FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 (K081712)Guangdong Biolight Meditech Co., Ltd.2008-09-12
RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L (K081659)Masimo Corporation2008-09-09
PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE (K081937)Philips Medizin Systeme Boeblingen GmbH2008-08-29
MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO (K081870)GE Healthcare Finland Oy2008-07-31
SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES (K073249)Solaris Medical Technology, Inc.2008-07-25
WRIST PULSE OXIMETER MD300W (K081125)Beijing Choice Electronic Technololgy Co., Ltd.2008-07-02
FINGER PULSE OXIMETER, MODEL 9560 (K081285)Nonin Medical, Inc.2008-06-05
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