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DQA

726 FDA 510(k) clearances · Product code

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RecordFirmDateBuilder
MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K040214)Masimo Corp.2004-02-25+ Add
PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T (K032979)Philips Medical Systems, Inc.2004-02-20+ Add
MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR (K032551)Masimo Corp.2004-02-19+ Add
MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V (K033296)Masimo Corp.2004-02-19+ Add
PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER (K033715)Philips Medical Systems, Inc.2004-02-13+ Add
AC-1 SP02 ADAPTOR CABLE, MODEL AC-1 (K033349)Masimo Corp.2004-01-28+ Add
SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS (K033298)Masimo Corp.2003-12-12+ Add
DRAEGER MICRO2+ AND MASIMO MINISAT (K032537)Draeger Medical Systems, Inc.2003-11-25+ Add
SPIROPRO SPO2 (K031515)Viasys Healthcare GmbH2003-11-14+ Add
NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 (K032947)Dolphin Medical, Inc.2003-10-17+ Add
MODEL 3100 WRISTOX PULSE OXIMETER (K030668)Nonin Medical, Inc.2003-10-17+ Add
MODEL 2100 PULSE OXIMETER (K031465)Dolphin Medical, Inc.2003-10-10+ Add
DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER (K030629)Dolphin Medical, Inc.2003-09-04+ Add
VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES (K031740)Welch Allyn Protocol, Inc.2003-08-26+ Add
BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER (K031742)Bci, Inc.2003-08-18+ Add
PICOSAT II SPO2 PULSE OXIMETRY MODULE (K030973)Philips Medical Systems2003-07-23+ Add
MODEL 9600, AVANT PULSE OXIMETER (K023044)Nonin Medical, Inc.2003-07-23+ Add
SIEMENS MICRO2+ WITH VAI SOFTWARE (K030640)Siemens Medical Solutions USA, Inc.2003-06-03+ Add
OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N (K030930)Nellcor Puritan Bennett, Inc.2003-05-23+ Add
DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421 (K030952)Dolphin Medical, Inc.2003-05-19+ Add
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K031330)Masimo Corp.2003-05-12+ Add
MICROCAP PLUS/NPB-75 (K024300)Oridion Medical 1987 , Ltd.2003-04-03+ Add
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER (K024235)Dolphin Medical, Inc.2003-03-17+ Add
IM2001 PULSE OXIMETER (K012706)Imagyn Medical Technologies, Inc.2003-03-07+ Add
MINOLTA PULSOX-2 (K021469)Konica Minolta Sensing, Inc.2003-02-12+ Add
VITALSAT SERIES (K011518)Beta Biomed Services, Inc.2002-11-15+ Add
OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' (K014218)Dolphin Medical, Inc.2002-11-07+ Add
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES (K021955)Datex-Ohmeda, Inc.2002-10-08+ Add
ATLAS MONITOR, MODELS 200,210,220 (K022084)Welch Allyn, Inc.2002-09-26+ Add
NELLCOR N-200 PULSE OXIMETER, MODEL N-200 (K022819)Nellcor Puritan Bennett, Inc.2002-09-24+ Add
WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 (K022163)Welch Allyn, Inc.2002-09-17+ Add
MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE (K022677)Alaris Medical Systems, Inc.2002-09-11+ Add
SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER (K022766)Siemens Medical Solutions USA, Inc.2002-09-05+ Add
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N (K022193)Ge Medical Systems Information Technologies2002-08-01+ Add
ENVOY (K022168)Mennen Medical , Ltd.2002-08-01+ Add
INFINITY MICRO2+ (K012770)Siemens Medical Solutions USA, Inc.2002-07-23+ Add
PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B (K021778)Philips Medical Systems2002-07-17+ Add
DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 (K021959)Dolphin Medical, Inc.2002-07-11+ Add
OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR (K021089)Nellcor Puritan Bennett, Inc.2002-06-19+ Add
BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR (K020739)Bci, Inc.2002-06-03+ Add
SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 (K021246)Sensidyne, Inc.2002-05-13+ Add
OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER (K021090)Nellcor Puritan Bennett, Inc.2002-05-08+ Add
BCI 3180 PULSE OXIMETER (K020350)Bci, Inc.2002-04-30+ Add
HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER (K014025)Hommed, LLC2002-04-09+ Add
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES (K020479)Datex-Ohmeda2002-03-26+ Add
DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 (K012989)Dolphin Medical, Inc.2002-03-20+ Add
OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) (K012891)Nellcor Puritan Bennett, Inc.2002-03-07+ Add
BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM (K013862)Bci, Inc.2002-02-21+ Add
SENSAID (K011974)Sensidyne, Inc.2002-02-12+ Add
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER (K020075)Dolphin Medical, Inc.2002-02-08+ Add
MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 (K014294)Medical Data Electronics2002-01-25+ Add
NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR (K013319)Nonin Medical, Inc.2002-01-03+ Add
3420 DIGIT PULSE OXIMETER, MODEL 3420 (K013171)Bci, Inc.2002-01-03+ Add
FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE (K013273)Fukuda Denshi USA, Inc.2001-12-20+ Add
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K013792)Masimo Corp.2001-12-11+ Add
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR (K012626)Osi Medical, Inc.2001-11-02+ Add
VITALSAT PULSE OXIMETER, MODEL IC32000 (K011365)Island Critical Care Corp.2001-10-26+ Add
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES (K012992)Masimo Corp.2001-10-03+ Add
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES (K012533)Osi Medical, Inc.2001-08-22+ Add
ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM (K011320)Hitachi Medical Systems America, Inc.2001-08-09+ Add
MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI (K010413)Konica Minolta Sensing, Inc.2001-08-02+ Add
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K011851)Masimo Corp.2001-07-11+ Add
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE (K011670)Datex-Ohmeda2001-06-26+ Add
BCI 3403 SLEEP SCREENING PULSE OXIMETER (K011156)Bci, Inc.2001-06-14+ Add
MEDLEY SP02 MODULE, MODEL 8220 (K010966)Alaris Medical Systems, Inc.2001-06-08+ Add
SPO2 WRAP SENSOR (K002848)Epic Medical Equipment Services, Inc.2001-05-24+ Add
NOVAMETRIX MARQUETTE COMPATIBLE SENSORS (K010451)Novametrix Medical Systems, Inc.2001-04-25+ Add
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD (K002036)Osi Medical, Inc.2001-04-17+ Add
PREAMP CABLE, MODEL B400-1011PA (K003542)Beta Biomed Services, Inc.2001-04-06+ Add
FINGER PULSE METER (K000814)Bhs Intl., Inc.2001-03-29+ Add
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES (K010463)Datex-Ohmeda, Inc.2001-03-15+ Add
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K010419)Masimo Corp.2001-03-06+ Add
HOMMED SENTRY III PATIENT MONITOR SYSTEM (K004044)Hommed, LLC2001-03-02+ Add
PROFOX SOFTWARE, MODEL 920M-41 (K001708)Respironics Georgia, Inc.2001-03-01+ Add
MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 (K002787)Palco Labs, Inc.2000-11-29+ Add
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K003167)Masimo Corp.2000-11-08+ Add
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K003244)Masimo Corp.2000-11-08+ Add
SOLAR SPO2 MODULE WITH MASIMO SET (K002957)General Electric Medical Systems Information Techn2000-10-18+ Add
MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 (K002690)Nonin Medical, Inc.2000-10-11+ Add
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER (K002939)Masimo Corp.2000-10-06+ Add
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K002751)Masimo Corp.2000-10-05+ Add
ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 (K001842)Somanetics Corp.2000-09-15+ Add
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K002682)Masimo Corp.2000-09-13+ Add
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES (K002477)Masimo Corp.2000-09-08+ Add
SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER (K001995)Qrs Diagnostic, LLC2000-09-08+ Add
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT (K002574)Masimo Corp.2000-09-06+ Add
MINOLTA PULSOX-3/MINOLTA PULSOX-3I (K984570)In-X Corp.2000-08-30+ Add
EPIC SPO2 FINGER SENSOR, MODEL E412-20 (K002223)Epic Medical Equipment Services, Inc.2000-08-22+ Add
MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 (K001930)Nonin Medical, Inc.2000-07-20+ Add
BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A (K001770)Bci, Inc.2000-07-05+ Add
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER (K001688)Datex-Ohmeda, Inc.2000-06-30+ Add
STAT-SHELL DISPOSABLE SP02 SENSOR (K000831)Epic Medical Equipment Services, Inc.2000-06-05+ Add
MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW (K001308)Agilent Technologies2000-05-17+ Add
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 (K001085)Nonin Medical, Inc.2000-05-01+ Add
MODEL 120 (K994372)Palco Labs, Inc.2000-04-28+ Add
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA (K000126)Masimo Corp.2000-04-14+ Add
MODIFICATION TO MARSPO2, MODEL 2001 (K000794)Novametrix Medical Systems, Inc.2000-04-10+ Add
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER (K993512)Datex-Ohmeda, Inc.2000-03-31+ Add
MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED (K992215)Envitec-Wismar GmbH2000-03-29+ Add
MARSPO2, MODEL 2001 (K993979)Novametrix Medical Systems, Inc.2000-02-22+ Add
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