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

Company510(k)sRecalls
Masimo Corp.7714
Nonin Medical, Inc.423
Oridion Medical 1987 , Ltd.132
Philips Healthcare Inc.025
Nellcor Puritan Bennett, Inc.194
Beijing Choice Electronic Technololgy Co., Ltd.210
Philips Medical Systems85
Covidien102
Dolphin Medical, Inc.120
Bci Intl., Inc.110
Decided510(k)Device and applicantCode
Feb 22, 2000K993979MARSPO2, MODEL 2001
Novametrix Medical Systems, Inc.
DQA
Jan 7, 2000K992455NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
Nihon Kohden America, Inc.
DQA
Dec 22, 1999K992211SPO2 WRAP SENSOR
Epic Medical Equipment Services, Inc.
DQA
Dec 22, 1999K992092STAT-SHELL DISPOSABLE SPO2 SENSOR
Epic Medical Equipment Services, Inc.
DQA
Dec 3, 1999K981655SPACELABS MEDICAL DISPOSABLE SP02 SENSOR
Spacelabs Medical, Inc.
DQA
Nov 24, 1999K993637N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS
Nellcor Puritan Bennett, Inc.
DQA
Nov 19, 1999K993555MASIMO SET/QUARTZ 2500 PULSE OXIMETER AND ACCESSORIES
Masimo Corp.
DQA
Oct 8, 1999K992340MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PE
Masimo Corp.
DQA
Oct 8, 1999K992238MASIMO SET RADICAL PULSE OXIMETER, LNOP-ADT, LNOP-PDT, LNOP-NEO, LNOP-NEO PT, LNOP-DCI, PATIENT CABLE (PC04, PC08, PC12)
Masimo Corp.
DQA
Aug 25, 1999K991823N-395 PULSE OXIMETER, MODEL N-395
Nellcor Puritan Bennett, Inc.
DQA
Aug 19, 1999K991819MAGNATEK 30
Magna Advanced Technologies, Inc.
DQA
Jun 9, 1999K9914103402 HANDHELD PULSE OXIMETER
Bci Intl., Inc.
DQA
Jun 7, 1999K990966MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNOP -PDT-PEDIATRIC/SMALL DIS
Masimo Corp.
DQA
May 28, 1999K991661SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
Siemens Medical Solutions USA, Inc.
DQA
Apr 9, 1999K990082EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09
Epic Medical Equipment Services, Inc.
DQA
Dec 7, 1998K982728NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C
Nellcor Puritan Bennett, Inc.
DQA
Nov 6, 1998K983684DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS
Datex-Ohmeda, Inc.
DQA
Nov 2, 1998K9827769303 NEONATAL/ADULT VITAL SIGNS MONITOR
Cas Medical Systems, Inc.
DQA
Oct 22, 1998K982255MODEL 2000 PULSE OXIMETER
Ivy Biomedical Systems, Inc.
DQA
Oct 6, 1998K973970SPO2 FINGER PROBES
Medical Cables, Inc.
DQA
Oct 2, 1998K982907MAGNATEK 40
Magna Advanced Technologies, Inc.
DQA
Sep 17, 1998K982405MTEK-1000
Magna Advanced Technologies, Inc.
DQA
Sep 11, 1998K982331KELLER PULSE OXIMETER, MODEL 850+
Keller Medical Specialties Products, Inc.
DQA
Aug 20, 1998K981939AUTOCORR PLUS; 3404 OXIMETER/ECG MONITOR
Bci Intl., Inc.
DQA
Jul 16, 1998K980879OSCILLOMATE NIBP / SP02 EMS MONITOR
Cas Medical Systems, Inc.
DQA
Jun 8, 1998K974292NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES
Nihon Kohden America, Inc.
DQA
Apr 30, 1998K970098E100 SERIES SPO2 SENSORS
Epic Medical Equipment Services, Inc.
DQA
Apr 24, 1998K980299APEX OXIMETER
Marquette Medical Systems, Inc.
DQA
Mar 25, 1998K980714BCI 3401 HANDHELD PULSE OXIMETER
Bci Intl., Inc.
DQA
Jan 16, 1998K973991METRON QA-510 SPO2 ANALYZER
Metron U.S., Inc.
DQA
Jan 8, 1998K973887MASIMO SET MS-1P PULSE OXIMETER AND THE LNOP SERIES OF SENSORS AND CABLES
Masimo Corp.
DQA
Nov 14, 1997K973147NPB-295 PULSE OXIMETER
Nellcor Puritan Bennett, Inc.
DQA
Oct 28, 1997K972829CRICKET 2000 RECORDING PULSE OXIMETER
Respironics, Inc.
DQA
Oct 21, 1997K972837NPB-290 PULSE OXIMETER (NPB-290)
Nellcor Puritan Bennett, Inc.
DQA
Oct 17, 1997K972786ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL9366
Alexander Mfg. Co.
DQA
Oct 10, 1997K971628SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)
Somanetics Corp.
DQA
Oct 8, 1997K971273INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF
Bio-Tek Instruments, Inc.
DQA
Sep 25, 1997K972468NPB-195 PULSE OXIMETER
Nellcor Puritan Bennett, Inc.
DQA
Sep 25, 1997K970061ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX)
Datascope Corp.
DQA
Sep 4, 1997K973222SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
Siemens Medical Solutions USA, Inc.
DQA
Aug 28, 1997K970769COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE FINGER SENSOR
Aristo Medical
DQA
Aug 25, 1997K971946NPB-190 PULSE OXIMETER (NPB-190)
Nellcor Puritan Bennett, Inc.
DQA
Aug 12, 1997K971828ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL0810-0115
Alexander Mfg. Co.
DQA
Aug 12, 1997K971827ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS71764
Alexander Mfg. Co.
DQA
Jul 16, 1997K965172OXIMETER PRE-AMP CABLE
Epic Medical Equipment Services, Inc.
DQA
Jul 16, 1997K964821COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67
Ventrex, Inc.
DQA
Jul 14, 1997K970763MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR
Medical Data Electronics
DQA
Jun 5, 1997K971235ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W
Alexander Mfg. Co.
DQA
May 21, 1997K964978VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
Quinton, Inc.
DQA
May 6, 1997K970368SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
Siemens Medical Solutions USA, Inc.
DQA

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