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DQA

726 FDA 510(k) clearances · Product code

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RecordFirmDateBuilder
NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES (K992455)Nihon Kohden America, Inc.2000-01-07+ Add
SPO2 WRAP SENSOR (K992211)Epic Medical Equipment Services, Inc.1999-12-22+ Add
STAT-SHELL DISPOSABLE SPO2 SENSOR (K992092)Epic Medical Equipment Services, Inc.1999-12-22+ Add
SPACELABS MEDICAL DISPOSABLE SP02 SENSOR (K981655)Spacelabs Medical, Inc.1999-12-03+ Add
N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS (K993637)Nellcor Puritan Bennett, Inc.1999-11-24+ Add
MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES (K993555)Masimo Corp.1999-11-19+ Add
MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12) (K992238)Masimo Corp.1999-10-08+ Add
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE (K992340)Masimo Corp.1999-10-08+ Add
N-395 PULSE OXIMETER, MODEL N-395 (K991823)Nellcor Puritan Bennett, Inc.1999-08-25+ Add
MAGNATEK 30 (K991819)Magna Advanced Technologies, Inc.1999-08-19+ Add
3402 HANDHELD PULSE OXIMETER (K991410)Bci Intl., Inc.1999-06-09+ Add
MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS (K990966)Masimo Corp.1999-06-07+ Add
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER (K991661)Siemens Medical Solutions USA, Inc.1999-05-28+ Add
EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09 (K990082)Epic Medical Equipment Services, Inc.1999-04-09+ Add
NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C (K982728)Nellcor Puritan Bennett, Inc.1998-12-07+ Add
DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS (K983684)Datex-Ohmeda, Inc.1998-11-06+ Add
9303 NEONATAL/ADULT VITAL SIGNS MONITOR (K982776)Cas Medical Systems, Inc.1998-11-02+ Add
MODEL 2000 PULSE OXIMETER (K982255)Ivy Biomedical Systems, Inc.1998-10-22+ Add
SPO2 FINGER PROBES (K973970)Medical Cables, Inc.1998-10-06+ Add
MAGNATEK 40 (K982907)Magna Advanced Technologies, Inc.1998-10-02+ Add
MTEK-1000 (K982405)Magna Advanced Technologies, Inc.1998-09-17+ Add
KELLER PULSE OXIMETER, MODEL 850+ (K982331)Keller Medical Specialties Products, Inc.1998-09-11+ Add
AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR (K981939)Bci Intl., Inc.1998-08-20+ Add
OSCILLOMATE NIBP / SP02 EMS MONITOR (K980879)Cas Medical Systems, Inc.1998-07-16+ Add
NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES (K974292)Nihon Kohden America, Inc.1998-06-08+ Add
E100 SERIES SPO2 SENSORS (K970098)Epic Medical Equipment Services, Inc.1998-04-30+ Add
APEX OXIMETER (K980299)Marquette Medical Systems, Inc.1998-04-24+ Add
BCI 3401 HANDHELD PULSE OXIMETER (K980714)Bci Intl., Inc.1998-03-25+ Add
METRON QA-510 SPO2 ANALYZER (K973991)Metron U.S., Inc.1998-01-16+ Add
MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES (K973887)Masimo Corp.1998-01-08+ Add
NPB-295 PULSE OXIMETER (K973147)Nellcor Puritan Bennett, Inc.1997-11-14+ Add
CRICKET 2000 RECORDING PULSE OXIMETER (K972829)Respironics, Inc.1997-10-28+ Add
NPB-290 PULSE OXIMETER (NPB-290) (K972837)Nellcor Puritan Bennett, Inc.1997-10-21+ Add
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366 (K972786)Alexander Mfg. Co.1997-10-17+ Add
SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) (K971628)Somanetics Corp.1997-10-10+ Add
INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF (K971273)Bio-Tek Instruments, Inc.1997-10-08+ Add
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) (K970061)Datascope Corp.1997-09-25+ Add
NPB-195 PULSE OXIMETER (K972468)Nellcor Puritan Bennett, Inc.1997-09-25+ Add
SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER (K973222)Siemens Medical Solutions USA, Inc.1997-09-04+ Add
COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR (K970769)Aristo Medical1997-08-28+ Add
NPB-190 PULSE OXIMETER (NPB-190) (K971946)Nellcor Puritan Bennett, Inc.1997-08-25+ Add
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115 (K971828)Alexander Mfg. Co.1997-08-12+ Add
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764 (K971827)Alexander Mfg. Co.1997-08-12+ Add
COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 (K964821)Ventrex, Inc.1997-07-16+ Add
OXIMETER PRE-AMP CABLE (K965172)Epic Medical Equipment Services, Inc.1997-07-16+ Add
MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR (K970763)Medical Data Electronics1997-07-14+ Add
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W (K971235)Alexander Mfg. Co.1997-06-05+ Add
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) (K964978)Quinton, Inc.1997-05-21+ Add
SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER (K970368)Siemens Medical Solutions USA, Inc.1997-05-06+ Add
FLEXI-SITE (E203-01)/ FLEXI-FIT (E300) (K964055)Epic Medical Equipment Services, Inc.1997-02-21+ Add
8500A PULSE OXIMETER (K945290)Nonin Medical, Inc.1997-02-11+ Add
MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES (K962603)Masimo Corp.1997-02-06+ Add
NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) (K963707)Nellcor Puritan Bennett, Inc.1996-12-13+ Add
SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE (K952315)Emg Scientific1996-12-04+ Add
OXI TEMP (K963496)Bci Intl., Inc.1996-11-26+ Add
OHMEDA 3800 PULSE OXIMETER (K962127)Ohmeda Medical1996-10-10+ Add
E100A PULSE OXIMETER FINGER SENSOR/PROBE (K954168)Epic Medical Equipment Services, Inc.1996-09-12+ Add
3304 PULSE OXIMETER (K962156)Bci Intl., Inc.1996-08-28+ Add
SCORE SOFTWARE (K961450)Nellcor Puritan Bennett, Inc.1996-08-01+ Add
SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) (K960614)Somanetics Corp.1996-06-05+ Add
OXITEMP, 3301T SA (K960058)Bci Intl., Inc.1996-05-15+ Add
BURDICK 200 PULSE OXIMETER (K954267)Burdick, Inc.1996-05-03+ Add
COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL DISPOSABLE SENSOR AND COMSAT REUSABLE FINGER SENSOR (K960251)Aristo Medical Products, Inc.1996-03-26+ Add
9267 SPO2 ATHENA MODULE (K940933)S & W Medico Teknik1995-11-29+ Add
ARISTO MEDICAL MODEL 2101 PATIENT MONITOR (K953817)Aristo Medical Products, Inc.1995-11-22+ Add
OXILINK (SMALL, MEDIUM, LARGE) (K953126)Bci Intl., Inc.1995-09-21+ Add
SMARTSAT PULSE OXIMETRY ANALYZER (K952327)Clinical Dynamics Corp.1995-08-25+ Add
NELLCOR SYMPHONY N-3000 PULSE OXIMETER (K952316)Nellcor, Inc.1995-08-17+ Add
NELLCOR N-20PA PORTABLE PULSE OXIMETER (K952222)Nellcor, Inc.1995-08-15+ Add
NEWOX2 (K945754)Bci Intl., Inc.1995-07-17+ Add
NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000 (K942347)Nellcor, Inc.1995-05-12+ Add
PULSE OXIMETER MODEL 305 (K943842)Palco Laboratories, Inc.1995-03-24+ Add
3301T OXITEMP (K946185)Bci Intl., Inc.1995-03-17+ Add
HEWLETT-PACKARD M1021A MIX VEN OXY SAT PLUG-IN MODULE (K942842)Hewlett-Packard GmbH1995-02-16+ Add
FUKUDA DENSHI MODE HG-302 PULSE OXIMETER MODULE (K945464)Fukuda Denshi USA, Inc.1995-02-01+ Add
MINIATURIZED FINGER CLIP PULSE OXIMETER (K942248)Nonin Medical, Inc.1994-12-08+ Add
MARQUETTE ADULT/NEONATAL WRAP SENSOR (K943817)Marquette Electronics, Inc.1994-10-18+ Add
AS/3 NELLCOR COMPATIBLE SATURATION MOODULE, M-NSAT (K943456)Datex Division Instrumentarium Corp.1994-10-17+ Add
BURDICK PRO2 OXIMETER (K941351)Burdick Corp.1994-10-13+ Add
3301 PULSE OXIMETER (K943404)Bci Intl., Inc.1994-10-13+ Add
HP M1722A/B AND M1723A/B CODEMASTER (K944608)Hewlett-Packard Co.1994-10-04+ Add
OHMEDA HAND HELD OXIMETER (K931304)Ohmeda Medical1994-09-29+ Add
INDEX SPO2 SIMULATOR (K933519)Bio-Tek Instruments, Inc.1994-09-01+ Add
SENSOR SHIELD, MODIFICATION (K933755)Medical Taping Systems, Inc.1994-08-16+ Add
VITALMAX 530 (K932203)Pace Tech Medical Monitors, Inc.1994-07-19+ Add
VX4 RECORDING PULSE OXIMETER (K935510)Vitalog Monitoring,Inc.1994-07-01+ Add
PULSE OXIMETER (K941289)Bci Intl., Inc.1994-06-22+ Add
BIOCHEM MODEL 3302 NEWOX2 OXIMETER (K920083)Biochem International, Inc.1994-04-11+ Add
FUKUDA DENSHI MODEL HG-301 (K921454)Fukuda Denshi USA, Inc.1994-04-01+ Add
OXISAT (K934091)Marquette Electronics, Inc.1994-03-15+ Add
NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS (K940463)Nonin Medical, Inc.1994-03-14+ Add
NOVAMETRIX MODEL 510 (K924626)Novametrix Medical Systems, Inc.1993-12-03+ Add
FREEDOM OXIMETER/EEG DIGITAL INTERFACE (K924752)Pro-Tech, Inc.1993-09-10+ Add
SDI OXYGEN/DIGITAL OXYGEN TRANSDUCERS (DOT) (K920966)Aristo Medical Products, Inc.1993-07-16+ Add
NELLCOR PORTABLE PULSE OXIMETER MODEL N-20 (K915699)Nellcor, Inc.1993-05-27+ Add
MODEL 3500 MR-COMPATIBLE PULSE OXIMETER (K924285)Magnetic Resonance Equipment Corp.1993-05-11+ Add
MODEL 320 MR-COMPATIBLE PULSE OXIMETER (K924282)Magnetic Resonance Equipment Corp.1993-05-07+ Add
PALCO LABS MODEL 340 PULSE OXIMETER (K920066)Palco Laboratories, Inc.1993-03-16+ Add
9293/1 INTERFACE MODULE (K923418)S & W Medico Teknik1993-02-23+ Add
OXYSHUTTLE II ,MODIFICATION (K925542)Sensor Medics Corp.1993-02-17+ Add
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