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 |
|---|---|---|---|
| Mar 11, 2004 | K033876 | DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 Dolphin Medical, Inc. | DQA |
| Feb 25, 2004 | K040214 | MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. | DQA |
| Feb 20, 2004 | K032979 | PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T Philips Medical Systems, Inc., DE | DQA |
| Feb 19, 2004 | K033296 | MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V Masimo Corp. | DQA |
| Feb 19, 2004 | K032551 | MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR Masimo Corp. | DQA |
| Feb 13, 2004 | K033715 | PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER Philips Medical Systems, Inc. | DQA |
| Jan 28, 2004 | K033349 | AC-1 SP02 ADAPTOR CABLE, MODEL AC-1 Masimo Corp. | DQA |
| Dec 12, 2003 | K033298 | SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS Masimo Corp. | DQA |
| Nov 25, 2003 | K032537 | DRAEGER MICRO2+ AND MASIMO MINISAT Draeger Medical Systems, Inc. | DQA |
| Nov 14, 2003 | K031515 | SPIROPRO SPO2 Viasys Healthcare GmbH | DQA |
| Oct 17, 2003 | K032947 | NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 Dolphin Medical, Inc. | DQA |
| Oct 17, 2003 | K030668 | MODEL 3100 WRISTOX PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Oct 10, 2003 | K031465 | MODEL 2100 PULSE OXIMETER Dolphin Medical, Inc. | DQA |
| Sep 4, 2003 | K030629 | DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER Dolphin Medical, Inc. | DQA |
| Aug 26, 2003 | K031740 | VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES Welch Allyn Protocol, Inc. | DQA |
| Aug 18, 2003 | K031742 | BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER Bci, Inc. | DQA |
| Jul 23, 2003 | K030973 | PICOSAT II SPO2 PULSE OXIMETRY MODULE Philips Medical Systems | DQA |
| Jul 23, 2003 | K023044 | MODEL 9600, AVANT PULSE OXIMETER Nonin Medical, Inc. | DQA |
| Jun 3, 2003 | K030640 | SIEMENS MICRO2+ WITH VAI SOFTWARE Siemens Medical Solutions USA, Inc. | DQA |
| May 23, 2003 | K030930 | OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N Nellcor Puritan Bennett, Inc. | DQA |
| May 19, 2003 | K030952 | DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421 Dolphin Medical, Inc. | DQA |
| May 12, 2003 | K031330 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES Masimo Corp. | DQA |
| Apr 3, 2003 | K024300 | MICROCAP PLUS/NPB-75 Oridion Medical 1987 , Ltd., IL | DQA |
| Mar 17, 2003 | K024235 | DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER Dolphin Medical, Inc. | DQA |
| Mar 7, 2003 | K012706 | IM2001 PULSE OXIMETER Imagyn Medical Technologies, Inc. | DQA |
| Feb 12, 2003 | K021469 | MINOLTA PULSOX-2 Konica Minolta Sensing, Inc. | DQA |
| Nov 15, 2002 | K011518 | VITALSAT SERIES Beta Biomed Services, Inc. | DQA |
| Nov 7, 2002 | K014218 | OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' Dolphin Medical, Inc. | DQA |
| Oct 8, 2002 | K021955 | TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES Datex-Ohmeda, Inc. | DQA |
| Sep 26, 2002 | K022084 | ATLAS MONITOR, MODELS 200,210,220 Welch Allyn, Inc. | DQA |
| Sep 24, 2002 | K022819 | NELLCOR N-200 PULSE OXIMETER, MODEL N-200 Nellcor Puritan Bennett, Inc. | DQA |
| Sep 17, 2002 | K022163 | WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 Welch Allyn, Inc. | DQA |
| Sep 11, 2002 | K022677 | MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE Alaris Medical Systems, Inc. | DQA |
| Sep 5, 2002 | K022766 | SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER Siemens Medical Solutions USA, Inc. | DQA |
| Aug 1, 2002 | K022193 | DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N Ge Medical Systems Information Technologies | DQA |
| Aug 1, 2002 | K022168 | ENVOY Mennen Medical , Ltd. | DQA |
| Jul 23, 2002 | K012770 | INFINITY MICRO2+ Siemens Medical Solutions USA, Inc. | DQA |
| Jul 17, 2002 | K021778 | PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B Philips Medical Systems | DQA |
| Jul 11, 2002 | K021959 | DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 Dolphin Medical, Inc. | DQA |
| Jun 19, 2002 | K021089 | OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR Nellcor Puritan Bennett, Inc. | DQA |
| Jun 3, 2002 | K020739 | BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR Bci, Inc. | DQA |
| May 13, 2002 | K021246 | SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 Sensidyne, Inc. | DQA |
| May 8, 2002 | K021090 | OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER Nellcor Puritan Bennett, Inc. | DQA |
| Apr 30, 2002 | K020350 | BCI 3180 PULSE OXIMETER Bci, Inc. | DQA |
| Apr 9, 2002 | K014025 | HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER Hommed, LLC | DQA |
| Mar 26, 2002 | K020479 | DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES Datex-Ohmeda | DQA |
| Mar 20, 2002 | K012989 | DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 Dolphin Medical, Inc. | DQA |
| Mar 7, 2002 | K012891 | OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) Nellcor Puritan Bennett, Inc. | DQA |
| Feb 21, 2002 | K013862 | BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM Bci, Inc. | DQA |
| Feb 12, 2002 | K011974 | SENSAID Sensidyne, Inc. | DQA |
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