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)
Top companies in DQA
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 8, 2002 | K020075 | MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER Dolphin Medical, Inc. | DQA |
| Jan 25, 2002 | K014294 | MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 Medical Data Electronics | DQA |
| Jan 3, 2002 | K013319 | NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR Nonin Medical, Inc. | DQA |
| Jan 3, 2002 | K013171 | 3420 DIGIT PULSE OXIMETER, MODEL 3420 Bci, Inc. | DQA |
| Dec 20, 2001 | K013273 | FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE Fukuda Denshi USA, Inc. | DQA |
| Dec 11, 2001 | K013792 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. | DQA |
| Nov 2, 2001 | K012626 | OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR Osi Medical, Inc. | DQA |
| Oct 26, 2001 | K011365 | VITALSAT PULSE OXIMETER, MODEL IC32000 Island Critical Care Corp., CA | DQA |
| Oct 3, 2001 | K012992 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES Masimo Corp. | DQA |
| Aug 22, 2001 | K012533 | MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES Osi Medical, Inc. | DQA |
| Aug 9, 2001 | K011320 | ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM Hitachi Medical Systems America, Inc. | DQA |
| Aug 2, 2001 | K010413 | MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI Konica Minolta Sensing, Inc. | DQA |
| Jul 11, 2001 | K011851 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. | DQA |
| Jun 26, 2001 | K011670 | DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE Datex-Ohmeda | DQA |
| Jun 14, 2001 | K011156 | BCI 3403 SLEEP SCREENING PULSE OXIMETER Bci, Inc. | DQA |
| Jun 8, 2001 | K010966 | MEDLEY SP02 MODULE, MODEL 8220 Alaris Medical Systems, Inc. | DQA |
| May 24, 2001 | K002848 | SPO2 WRAP SENSOR Epic Medical Equipment Services, Inc. | DQA |
| Apr 25, 2001 | K010451 | NOVAMETRIX MARQUETTE COMPATIBLE SENSORS Novametrix Medical Systems, Inc. | DQA |
| Apr 17, 2001 | K002036 | OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD Osi Medical, Inc. | DQA |
| Apr 6, 2001 | K003542 | PREAMP CABLE, MODEL B400-1011PA Beta Biomed Services, Inc. | DQA |
| Mar 29, 2001 | K000814 | FINGER PULSE METER Bhs Intl., Inc. | DQA |
| Mar 15, 2001 | K010463 | DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES Datex-Ohmeda, Inc. | DQA |
| Mar 6, 2001 | K010419 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. | DQA |
| Mar 2, 2001 | K004044 | HOMMED SENTRY III PATIENT MONITOR SYSTEM Hommed, LLC | DQA |
| Mar 1, 2001 | K001708 | PROFOX SOFTWARE, MODEL 920M-41 Respironics Georgia, Inc. | DQA |
| Nov 29, 2000 | K002787 | MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 Palco Labs, Inc. | DQA |
| Nov 8, 2000 | K003244 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. | DQA |
| Nov 8, 2000 | K003167 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. | DQA |
| Oct 18, 2000 | K002957 | SOLAR SPO2 MODULE WITH MASIMO SET General Electric Medical Systems Information Techn | DQA |
| Oct 11, 2000 | K002690 | MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 Nonin Medical, Inc. | DQA |
| Oct 6, 2000 | K002939 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER Masimo Corp. | DQA |
| Oct 5, 2000 | K002751 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. | DQA |
| Sep 15, 2000 | K001842 | ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 Somanetics Corp. | DQA |
| Sep 13, 2000 | K002682 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. | DQA |
| Sep 8, 2000 | K002477 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. | DQA |
| Sep 8, 2000 | K001995 | SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER Qrs Diagnostic, LLC | DQA |
| Sep 6, 2000 | K002574 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT Masimo Corp. | DQA |
| Aug 30, 2000 | K984570 | MINOLTA PULSOX-3/MINOLTA PULSOX-3I In-X Corp. | DQA |
| Aug 22, 2000 | K002223 | EPIC SPO2 FINGER SENSOR, MODEL E412-20 Epic Medical Equipment Services, Inc. | DQA |
| Jul 20, 2000 | K001930 | MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 Nonin Medical, Inc. | DQA |
| Jul 5, 2000 | K001770 | BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A Bci, Inc. | DQA |
| Jun 30, 2000 | K001688 | DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER Datex-Ohmeda, Inc. | DQA |
| Jun 5, 2000 | K000831 | STAT-SHELL DISPOSABLE SP02 SENSOR Epic Medical Equipment Services, Inc. | DQA |
| May 17, 2000 | K001308 | MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW Agilent Technologies | DQA |
| May 1, 2000 | K001085 | MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 Nonin Medical, Inc. | DQA |
| Apr 28, 2000 | K994372 | MODEL 120 Palco Labs, Inc. | DQA |
| Apr 14, 2000 | K000126 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA Masimo Corp. | DQA |
| Apr 10, 2000 | K000794 | MODIFICATION TO MARSPO2, MODEL 2001 Novametrix Medical Systems, Inc. | DQA |
| Mar 31, 2000 | K993512 | DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER Datex-Ohmeda, Inc. | DQA |
| Mar 29, 2000 | K992215 | MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED Envitec-Wismar GmbH | DQA |
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