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 4 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K081285 | FINGER PULSE OXIMETER, MODEL 9560 | Nonin Medical, Inc. | 2008-06-05 | Special | PDF ↗ |
| K080255 | NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER | Nonin Medical, Inc. | 2008-05-23 | Special | PDF ↗ |
| K080238 | MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER | Masimo Corporation | 2008-05-12 | Traditional | PDF ↗ |
| K073454 | FINGERTIP PULSE OXIMETER, MODEL CMS-50C | Contec Medical System Co., Ltd. | 2008-05-05 | Traditional | PDF ↗ |
| K071642 | MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER | Mediaid, Inc. | 2008-05-02 | Traditional | PDF ↗ |
| K073036 | FORE-SIGHT, MC-2000 SERIES | Cas Medical Systems, Inc. | 2008-02-25 | Traditional | PDF ↗ |
| K073024 | MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES | Masimo Corporation | 2008-02-08 | Special | PDF ↗ |
| K072825 | FINGERTIP PULSE OXIMETER, MODEL MD300I | Beijing Choice Electronic Technololgy Co., Ltd. | 2008-01-14 | Special | PDF ↗ |
| K072581 | PM-60 PULSE OXIMETER | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-01-08 | Traditional | PDF ↗ |
| K071610 | MEDIAID PULSE OXIMETER M30 AND M34 | Mediaid, Inc. | 2007-11-05 | Traditional | PDF ↗ |
| K072235 | PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-10-19 | Special | PDF ↗ |
| K072295 | CAPNOSTREAM 20 WITH A2 ADAPTIVE AVERAGING SOFTWARE | Oridion Capnography, Inc. | 2007-10-11 | Special | PDF ↗ |
| K071672 | SENTEC DIGITAL MONITORING SYSTEM | Sentec AG | 2007-09-12 | Traditional | PDF ↗ |
| K070371 | FINGERTIP PULSE OXIMETER MD300C | Beijing Choice Electronic Technololgy Co., Ltd. | 2007-08-13 | Traditional | PDF ↗ |
| K071415 | DIGITAL PULSE OXIMETER, MODEL 7500FO | Nonin Medical, Inc. | 2007-08-08 | Traditional | PDF ↗ |
| K063641 | PC-60, NON-INVASIVEPULSE OXIMETER | Shenzhen Creative Industry Co., Ltd. | 2007-07-13 | Traditional | PDF ↗ |
| K071285 | DIGITAL PULSE OXIMETER, MODEL 7500 | Nonin Medical, Inc. | 2007-07-12 | Special | PDF ↗ |
| K070732 | BCI AUTOCON 3304 DIGITAL PULSE OXIMETER | Smiths Medical Pm, Inc. | 2007-07-09 | Traditional | PDF ↗ |
| K071024 | MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS | Masimo Corporation | 2007-06-29 | Special | PDF ↗ |
| K062149 | SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES | International Business Strategies | 2007-05-31 | Traditional | PDF ↗ |
| K070408 | DURAMAX REUSABLE OXIMETRY SENSOR | Nellcor Puritan Bennett, Inc. | 2007-05-25 | Abbreviated | PDF ↗ |
| K062724 | ACCUPULSE PULSE OXIMETER | Eagle Medical Equipment Co. | 2007-05-11 | Traditional | PDF ↗ |
| K063752 | LIFESENSE, MODEL LS1-9R | Nonin Medical, Inc. | 2007-05-04 | Traditional | PDF ↗ |
| K070193 | ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES | Envitec-Wismar GmbH | 2007-05-02 | Traditional | PDF ↗ |
| K063783 | PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A | Philips Medical Systems, Inc. | 2007-04-27 | Special | PDF ↗ |
| K061896 | MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N | Mediaid, Inc. | 2007-04-12 | Traditional | PDF ↗ |
| K061706 | CADWELL EASYNET OXIMETER MODULE | Cadwell Laboratories, Inc. | 2007-03-05 | Traditional | PDF ↗ |
| K061931 | SOLARIS COMPATIBLE REUSABLE ADULT SPO2 FINGER SENSORS, MODELS S100A-090103 AND 300103, S200A-090101 AND 300101 | Solaris Medical Technology, Inc. | 2007-01-31 | Traditional | PDF ↗ |
| K063434 | TOSCA 500 TCPCO2, SPO2 AND PULSE RATE MONITORING SYSTEM | Radiometer Basel AG | 2007-01-22 | Traditional | PDF ↗ |
| K063140 | RAINBOW ADHESIVE CO-OXIMETRY SENSORS | Masimo Corporation | 2006-12-29 | Special | PDF ↗ |
| K053420 | TENACORE SP02 SENSORS | Tenacore Holdings, Inc. | 2006-11-15 | Traditional | PDF ↗ |
| K062605 | PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T | Philips Medical Systems | 2006-11-09 | Special | PDF ↗ |
| K062455 | PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL | Philips Medical Systems | 2006-11-03 | Special | PDF ↗ |
| K062338 | TELEVISIT | PHD Medical | 2006-10-25 | Traditional | PDF ↗ |
| K062268 | MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03 | Philips Medical Systems North America Co. | 2006-10-18 | Special | PDF ↗ |
| K052544 | PULSE OXIMETER ADAPTER CABLES | American I.V. Products, Inc. | 2006-09-29 | Abbreviated | PDF ↗ |
| K061442 | PULSE OXIMETER, MODEL PM-50 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-09-05 | Special | PDF ↗ |
| K060576 | NELLCOR OXIMAX N-600X PULSE OXIMETER | Nellcor Puritan Bennett, Inc. | 2006-08-14 | Traditional | PDF ↗ |
| K061204 | MASIMO SET RADICAL 7 PULSE CO-OXIMETER | Masimo Corporation | 2006-07-27 | Traditional | PDF ↗ |
| K060675 | ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS | Envitec-Wismar GmbH | 2006-07-17 | Special | PDF ↗ |
| K061329 | INFINITY MASIMO SET SP02 POD | Draeger Medical Systems, Inc. | 2006-07-07 | Special | PDF ↗ |
| K060616 | NPOSES (NOCTURNAL PULSE OXIMETRY STUDY EXPERT SYSTEM), MODEL NPOSES-100 | PHD Medical | 2006-06-29 | Traditional | PDF ↗ |
| K060143 | LNCS AND SPO2.COM SENSORS | Masimo Corporation | 2006-06-16 | Traditional | PDF ↗ |
| K053381 | WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE | Welch Allyn, Inc. | 2006-06-15 | Abbreviated | PDF ↗ |
| K060524 | DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES | Dolphin Medical, Inc. | 2006-06-15 | Special | PDF ↗ |
| K061191 | FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2 | Measurement Specialties, Inc. | 2006-05-22 | Special | PDF ↗ |
| K061112 | CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M | Conmed Corporation | 2006-05-22 | Special | PDF ↗ |
| K053419 | KONICA MINOLTA PULSOX-300, 300I | Konica Minolta Sensing, Inc. | 2006-05-11 | Traditional | PDF ↗ |
| K060065 | CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR | Oridion Capnography, Inc. | 2006-05-04 | Traditional | PDF ↗ |
| K060843 | MODIFICATION TO HEALTH BUDDY APPLIANCE | Health Hero Network, Inc. | 2006-04-20 | Special | PDF ↗ |
| K052693 | PM-50 PULSE OXIMETER | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-03-30 | Traditional | PDF ↗ |
| K053477 | MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS | Masimo Corporation | 2006-03-16 | Traditional | PDF ↗ |
| K053130 | ONYX II FINGER PULSE OXIMETER, MODEL 9550 | Nonin Medical, Inc. | 2006-01-11 | Traditional | PDF ↗ |
| K051271 | OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR | Nellcor Puritan Bennett, Inc. | 2006-01-10 | Traditional | PDF ↗ |
| K052619 | THE FINGER GUARD | T F & G Products | 2006-01-06 | Traditional | PDF ↗ |
| K052669 | AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100 | Nonin Medical, Inc. | 2005-12-23 | Traditional | PDF ↗ |
| K051257 | ADULT CEREBRAL OXIMETER, MODEL 2040 | Cas Medical Systems, Inc. | 2005-12-22 | Traditional | PDF ↗ |
| K053269 | MASIMO SET RAD-8 PULSE OXIMETER | Masimo Corporation | 2005-12-21 | Special | PDF ↗ |
| K051736 | FOX PULSE OXIMETER | Shunsuke Nakanishi | 2005-12-02 | Traditional | PDF ↗ |
| K052377 | PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A. | Philips Medizin Systeme Boeblingen GmbH | 2005-11-17 | Abbreviated | PDF ↗ |
| K052829 | WRISTOX MODEL 3100 PULSE OXIMETER | Nonin Medical, Inc. | 2005-11-10 | Traditional | PDF ↗ |
| K052186 | NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P | Nellcor Puritan Bennett, Inc. | 2005-11-10 | Special | PDF ↗ |
| K052755 | DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT | GE Healthcare | 2005-10-13 | Special | PDF ↗ |
| K051352 | OXIMAX NPB-40 HANDHELD PULSE OXIMETER | Nellcor Puritan Bennett, Inc. | 2005-08-11 | Traditional | PDF ↗ |
| K051439 | LNOP BLUE OXIMETRY SENSOR | Masimo Corporation | 2005-07-15 | Traditional | PDF ↗ |
| K051212 | MODIFICATION TO LNCS OXIMETRY SENSORS | Masimo Corporation | 2005-07-12 | Special | PDF ↗ |
| K050018 | TESLAOXYSAT, MODEL EFOXYSATE | Mammendorfer Institute For Physics & Medicine GmbH | 2005-07-01 | Traditional | PDF ↗ |
| K050844 | 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL | Cas Medical Systems, Inc. | 2005-06-23 | Traditional | PDF ↗ |
| K050056 | MODEL 2500A PALMSAT PULSE OXIMETER | Nonin Medical, Inc. | 2005-06-21 | Traditional | PDF ↗ |
| K051107 | ONYX II FINGER PULSE OXIMETER, MODEL 9550 | Nonin Medical, Inc. | 2005-06-01 | Special | PDF ↗ |
| K050252 | AC-1 ADAPTER CABLE, 8 PIN AND 12 PIN PHILIPS | Masimo Corporation | 2005-05-11 | Special | PDF ↗ |
| K043463 | ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS | Envitec-Wismar GmbH | 2005-02-11 | Traditional | PDF ↗ |
| K050068 | LNOPV AD-L AND PD-L OXIMETRY SENSORS | Masimo Corporation | 2005-02-09 | Special | PDF ↗ |
| K042536 | MASIMO SET RAD 57 PULSE CO-OXIMETER | Masimo Corporation | 2005-01-19 | Traditional | PDF ↗ |
| K043359 | 4100 PATIENT OXIMETER MODULE | Nonin Medical, Inc. | 2005-01-07 | Traditional | PDF ↗ |
| K042705 | DISPOSABLE NON-ADHESIVE SPO2 SENSORS | Elekon Industries U.S.A., Inc. | 2004-12-29 | Traditional | PDF ↗ |
| K043162 | PMP4 OXY PRO | Card Guard Scientific Survival , Ltd. | 2004-12-29 | Traditional | PDF ↗ |
| K042704 | REUSABLE FINGER CLIP SPO2 SENSORS | Elekon Industries U.S.A., Inc. | 2004-11-26 | Traditional | PDF ↗ |
| K042306 | PHILIPS SP02 DISPOSABLE SENSOR, MODEL M1131A | Philips Medizin Systeme Boeblingen GmbH | 2004-10-15 | Abbreviated | PDF ↗ |
| K042501 | ETG-4000 OPTICAL TOPOGRAPHY SYSTEM | Hitachi Medical Corp. | 2004-10-12 | Special | PDF ↗ |
| K042346 | LNCS OXIMETRY SENSORS | Masimo Corporation | 2004-09-20 | Special | PDF ↗ |
| K041522 | FLEXI-STAT DISPOSABLE ADHESIVE SPO2 SENSORS | Elekon Industries U.S.A., Inc. | 2004-09-14 | Traditional | PDF ↗ |
| K041964 | MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS | Mediaid, Inc. | 2004-09-14 | Traditional | PDF ↗ |
| K040178 | PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE | S.P.O. Medical Equipment, Ltd. | 2004-09-10 | Traditional | PDF ↗ |
| K041647 | FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE) | Elekon Industries U.S.A., Inc. | 2004-09-02 | Traditional | PDF ↗ |
| K032831 | PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 | Conmed Corporation | 2004-08-31 | Traditional | PDF ↗ |
| K040380 | DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 | Dolphin Medical, Inc. | 2004-08-31 | Special | PDF ↗ |
| K032971 | TIDAL WAVE SP MODEL 710/715 AND 715 | Respironics Novametrix, Inc. | 2004-08-26 | Traditional | PDF ↗ |
| K032949 | SPOT CHECK PULSE OXIMETER,512/513 | Respironics Novametrix, Inc. | 2004-08-23 | Traditional | PDF ↗ |
| K041815 | LNCS OXIMETRY SENSORS | Masimo Corp. | 2004-07-29 | Special | PDF ↗ |
| K041644 | FLEXI-STAT DISPOSABLE NON-ADHESIVE SPO2 SENSORS, (NELLCOR-COMPATIBLE), (BCI-COMPATIBLE), (DATEX-COMPATIBLE) | Elekon Industries U.S.A., Inc. | 2004-07-29 | Traditional | PDF ↗ |
| K041674 | THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3814A SPO2 UNIT | Philips Medical Systems | 2004-07-19 | Special | PDF ↗ |
| K041204 | NC SP02 ADAPTER CABLE | Masimo Corp. | 2004-06-29 | Special | PDF ↗ |
| K041156 | AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODELS 4000, 4001 | Nonin Medical, Inc. | 2004-06-09 | Traditional | PDF ↗ |
| K040589 | MODIFICATION TO AVANT 9600 PULSE OXIMETER | Nonin Medical, Inc. | 2004-06-03 | Special | PDF ↗ |
| K040581 | MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM | Vitel Net | 2004-05-27 | Traditional | PDF ↗ |
| K032755 | MODEL 509M PULSE OXIMETER, MODEL 509M | Respironics Novametrix, Inc. | 2004-05-21 | Traditional | PDF ↗ |
| K033307 | NVISION DATA MANAGEMENT SOFTWARE | Nonin Medical, Inc. | 2004-05-06 | Traditional | PDF ↗ |
| K040259 | MASIMO SET INTELLIVUE PULSE OXIMETER MODULE | Masimo Corp. | 2004-04-22 | Traditional | PDF ↗ |
| K033998 | MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V | Masimo Corp. | 2004-03-19 | Traditional | PDF ↗ |
Product code DQA · Class II · Cardiovascular. Data: openFDA.