FDA Product Code
FDA Product Code DQA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2700
510(k) Clearances — 727 records · page 5 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K033876 | DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 | Dolphin Medical, Inc. | 2004-03-11 | Special | PDF ↗ |
| K040214 | MODIFICATION TO: MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES | Masimo Corp. | 2004-02-25 | Special | PDF ↗ |
| K032979 | PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T | Philips Medical Systems, Inc. | 2004-02-20 | Special | PDF ↗ |
| K032551 | MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR | Masimo Corp. | 2004-02-19 | Special | PDF ↗ |
| K033296 | MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V | Masimo Corp. | 2004-02-19 | Traditional | PDF ↗ |
| K033715 | PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER | Philips Medical Systems, Inc. | 2004-02-13 | Special | PDF ↗ |
| K033349 | AC-1 SP02 ADAPTOR CABLE, MODEL AC-1 | Masimo Corp. | 2004-01-28 | Special | PDF ↗ |
| K033298 | SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS | Masimo Corp. | 2003-12-12 | Special | PDF ↗ |
| K032537 | DRAEGER MICRO2+ AND MASIMO MINISAT | Draeger Medical Systems, Inc. | 2003-11-25 | Special | PDF ↗ |
| K031515 | SPIROPRO SPO2 | Viasys Healthcare GmbH | 2003-11-14 | Traditional | PDF ↗ |
| K030668 | MODEL 3100 WRISTOX PULSE OXIMETER | Nonin Medical, Inc. | 2003-10-17 | Traditional | PDF ↗ |
| K032947 | NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 | Dolphin Medical, Inc. | 2003-10-17 | Special | PDF ↗ |
| K031465 | MODEL 2100 PULSE OXIMETER | Dolphin Medical, Inc. | 2003-10-10 | Special | PDF ↗ |
| K030629 | DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER | Dolphin Medical, Inc. | 2003-09-04 | Traditional | PDF ↗ |
| K031740 | VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES | Welch Allyn Protocol, Inc. | 2003-08-26 | Traditional | PDF ↗ |
| K031742 | BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER | Bci, Inc. | 2003-08-18 | Traditional | PDF ↗ |
| K023044 | MODEL 9600, AVANT PULSE OXIMETER | Nonin Medical, Inc. | 2003-07-23 | Traditional | PDF ↗ |
| K030973 | PICOSAT II SPO2 PULSE OXIMETRY MODULE | Philips Medical Systems | 2003-07-23 | Special | PDF ↗ |
| K030640 | SIEMENS MICRO2+ WITH VAI SOFTWARE | Siemens Medical Solutions USA, Inc. | 2003-06-03 | Special | PDF ↗ |
| K030930 | OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N | Nellcor Puritan Bennett, Inc. | 2003-05-23 | Traditional | PDF ↗ |
| K030952 | DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421 | Dolphin Medical, Inc. | 2003-05-19 | Special | PDF ↗ |
| K031330 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES | Masimo Corp. | 2003-05-12 | Special | PDF ↗ |
| K024300 | MICROCAP PLUS/NPB-75 | Oridion Medical 1987 , Ltd. | 2003-04-03 | Special | PDF ↗ |
| K024235 | DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER | Dolphin Medical, Inc. | 2003-03-17 | Special | PDF ↗ |
| K012706 | IM2001 PULSE OXIMETER | Imagyn Medical Technologies, Inc. | 2003-03-07 | Traditional | PDF ↗ |
| K021469 | MINOLTA PULSOX-2 | Konica Minolta Sensing, Inc. | 2003-02-12 | Traditional | PDF ↗ |
| K011518 | VITALSAT SERIES | Beta Biomed Services, Inc. | 2002-11-15 | Traditional | PDF ↗ |
| K014218 | OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' | Dolphin Medical, Inc. | 2002-11-07 | Traditional | PDF ↗ |
| K021955 | TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES | Datex-Ohmeda, Inc. | 2002-10-08 | Special | PDF ↗ |
| K022084 | ATLAS MONITOR, MODELS 200,210,220 | Welch Allyn, Inc. | 2002-09-26 | Special | PDF ↗ |
| K022819 | NELLCOR N-200 PULSE OXIMETER, MODEL N-200 | Nellcor Puritan Bennett, Inc. | 2002-09-24 | Special | PDF ↗ |
| K022163 | WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 | Welch Allyn, Inc. | 2002-09-17 | Special | PDF ↗ |
| K022677 | MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE | Alaris Medical Systems, Inc. | 2002-09-11 | Special | PDF ↗ |
| K022766 | SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER | Siemens Medical Solutions USA, Inc. | 2002-09-05 | Special | PDF ↗ |
| K022168 | ENVOY | Mennen Medical , Ltd. | 2002-08-01 | Special | PDF ↗ |
| K022193 | DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N | Ge Medical Systems Information Technologies | 2002-08-01 | Special | PDF ↗ |
| K012770 | INFINITY MICRO2+ | Siemens Medical Solutions USA, Inc. | 2002-07-23 | Traditional | PDF ↗ |
| K021778 | PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B | Philips Medical Systems | 2002-07-17 | Traditional | PDF ↗ |
| K021959 | DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, MODEL 2100 | Dolphin Medical, Inc. | 2002-07-11 | Special | PDF ↗ |
| K021089 | OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR | Nellcor Puritan Bennett, Inc. | 2002-06-19 | Traditional | PDF ↗ |
| K020739 | BCI 3178 PEDIATRIC PULSE OXIMETRY SENSOR | Bci, Inc. | 2002-06-03 | Traditional | PDF ↗ |
| K021246 | SENSAID, MODELS# RC-NVA30-10; RC-CS140-10; RC-BC150-3 | Sensidyne, Inc. | 2002-05-13 | Special | PDF ↗ |
| K021090 | OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER | Nellcor Puritan Bennett, Inc. | 2002-05-08 | Special | PDF ↗ |
| K020350 | BCI 3180 PULSE OXIMETER | Bci, Inc. | 2002-04-30 | Traditional | PDF ↗ |
| K014025 | HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READER | Hommed, LLC | 2002-04-09 | Traditional | PDF ↗ |
| K020479 | DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES | Datex-Ohmeda | 2002-03-26 | Special | PDF ↗ |
| K012989 | DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070 | Dolphin Medical, Inc. | 2002-03-20 | Traditional | PDF ↗ |
| K012891 | OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES) | Nellcor Puritan Bennett, Inc. | 2002-03-07 | Traditional | PDF ↗ |
| K013862 | BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM | Bci, Inc. | 2002-02-21 | Traditional | PDF ↗ |
| K011974 | SENSAID | Sensidyne, Inc. | 2002-02-12 | Traditional | PDF ↗ |
| K020075 | MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER | Dolphin Medical, Inc. | 2002-02-08 | Special | PDF ↗ |
| K014294 | MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414 | Medical Data Electronics | 2002-01-25 | Special | PDF ↗ |
| K013171 | 3420 DIGIT PULSE OXIMETER, MODEL 3420 | Bci, Inc. | 2002-01-03 | Traditional | PDF ↗ |
| K013319 | NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR | Nonin Medical, Inc. | 2002-01-03 | Traditional | PDF ↗ |
| K013273 | FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE | Fukuda Denshi USA, Inc. | 2001-12-20 | Traditional | PDF ↗ |
| K013792 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES | Masimo Corp. | 2001-12-11 | Special | PDF ↗ |
| K012626 | OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR | Osi Medical, Inc. | 2001-11-02 | Traditional | PDF ↗ |
| K011365 | VITALSAT PULSE OXIMETER, MODEL IC32000 | Island Critical Care Corp. | 2001-10-26 | Traditional | PDF ↗ |
| K012992 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND MASIMO SERIES OF SENSORS AND CABLES | Masimo Corp. | 2001-10-03 | Special | PDF ↗ |
| K012533 | MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER AND ACCESSORIES | Osi Medical, Inc. | 2001-08-22 | Traditional | PDF ↗ |
| K011320 | ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM | Hitachi Medical Systems America, Inc. | 2001-08-09 | Traditional | PDF ↗ |
| K010413 | MINOLTA PULSOX-3SI, PULSOX-3IA, PULSOX-3LI | Konica Minolta Sensing, Inc. | 2001-08-02 | Traditional | PDF ↗ |
| K011851 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES | Masimo Corp. | 2001-07-11 | Special | PDF ↗ |
| K011670 | DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSORIES (WITH TRUTRAK+MOTION CORRECTION PERFORMANCE | Datex-Ohmeda | 2001-06-26 | Special | PDF ↗ |
| K011156 | BCI 3403 SLEEP SCREENING PULSE OXIMETER | Bci, Inc. | 2001-06-14 | Traditional | PDF ↗ |
| K010966 | MEDLEY SP02 MODULE, MODEL 8220 | Alaris Medical Systems, Inc. | 2001-06-08 | Traditional | PDF ↗ |
| K002848 | SPO2 WRAP SENSOR | Epic Medical Equipment Services, Inc. | 2001-05-24 | Traditional | PDF ↗ |
| K010451 | NOVAMETRIX MARQUETTE COMPATIBLE SENSORS | Novametrix Medical Systems, Inc. | 2001-04-25 | Abbreviated | PDF ↗ |
| K002036 | OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD | Osi Medical, Inc. | 2001-04-17 | Traditional | PDF ↗ |
| K003542 | PREAMP CABLE, MODEL B400-1011PA | Beta Biomed Services, Inc. | 2001-04-06 | Traditional | PDF ↗ |
| K000814 | FINGER PULSE METER | Bhs Intl., Inc. | 2001-03-29 | Traditional | PDF ↗ |
| K010463 | DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES | Datex-Ohmeda, Inc. | 2001-03-15 | Special | PDF ↗ |
| K010419 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES | Masimo Corp. | 2001-03-06 | Special | PDF ↗ |
| K004044 | HOMMED SENTRY III PATIENT MONITOR SYSTEM | Hommed, LLC | 2001-03-02 | Traditional | PDF ↗ |
| K001708 | PROFOX SOFTWARE, MODEL 920M-41 | Respironics Georgia, Inc. | 2001-03-01 | Traditional | PDF ↗ |
| K002787 | MODEL 120, OXYSOFT, INFRARED DATA CONVERTER, MODEL 120 | Palco Labs, Inc. | 2000-11-29 | Special | PDF ↗ |
| K003244 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES | Masimo Corp. | 2000-11-08 | Special | PDF ↗ |
| K003167 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES | Masimo Corp. | 2000-11-08 | Special | PDF ↗ |
| K002957 | SOLAR SPO2 MODULE WITH MASIMO SET | General Electric Medical Systems Information Techn | 2000-10-18 | Special | PDF ↗ |
| K002690 | MODEL 2500, PALMSAT HAND HELD PULSE OXIMETER, MODEL 2500 | Nonin Medical, Inc. | 2000-10-11 | Special | PDF ↗ |
| K002939 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENORS OXIMETER | Masimo Corp. | 2000-10-06 | Special | PDF ↗ |
| K002751 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES | Masimo Corp. | 2000-10-05 | Special | PDF ↗ |
| K001842 | ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100 | Somanetics Corp. | 2000-09-15 | Traditional | PDF ↗ |
| K002682 | MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES | Masimo Corp. | 2000-09-13 | Special | PDF ↗ |
| K001995 | SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER | Qrs Diagnostic, LLC | 2000-09-08 | Special | PDF ↗ |
| K002477 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES | Masimo Corp. | 2000-09-08 | Special | PDF ↗ |
| K002574 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT | Masimo Corp. | 2000-09-06 | Special | PDF ↗ |
| K984570 | MINOLTA PULSOX-3/MINOLTA PULSOX-3I | In-X Corp. | 2000-08-30 | Traditional | PDF ↗ |
| K002223 | EPIC SPO2 FINGER SENSOR, MODEL E412-20 | Epic Medical Equipment Services, Inc. | 2000-08-22 | Special | PDF ↗ |
| K001930 | MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500 | Nonin Medical, Inc. | 2000-07-20 | Special | PDF ↗ |
| K001770 | BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A | Bci, Inc. | 2000-07-05 | Special | PDF ↗ |
| K001688 | DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER | Datex-Ohmeda, Inc. | 2000-06-30 | Special | PDF ↗ |
| K000831 | STAT-SHELL DISPOSABLE SP02 SENSOR | Epic Medical Equipment Services, Inc. | 2000-06-05 | Traditional | PDF ↗ |
| K001308 | MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW | Agilent Technologies | 2000-05-17 | Special | PDF ↗ |
| K001085 | MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500 | Nonin Medical, Inc. | 2000-05-01 | Special | PDF ↗ |
| K994372 | MODEL 120 | Palco Labs, Inc. | 2000-04-28 | Traditional | PDF ↗ |
| K000126 | MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA | Masimo Corp. | 2000-04-14 | Traditional | PDF ↗ |
| K000794 | MODIFICATION TO MARSPO2, MODEL 2001 | Novametrix Medical Systems, Inc. | 2000-04-10 | Special | PDF ↗ |
| K993512 | DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER | Datex-Ohmeda, Inc. | 2000-03-31 | Special | PDF ↗ |
| K992215 | MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED | Envitec-Wismar GmbH | 2000-03-29 | Traditional | PDF ↗ |
Product code DQA · Class II · Cardiovascular. Data: openFDA.