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 3 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K120052 | CVINSIGHT | Intelomed, Inc. | 2012-09-04 | Traditional | PDF ↗ |
| K121912 | E1 EAR SENSORS | Masimo Corporation | 2012-07-24 | Special | PDF ↗ |
| K120773 | NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM | Covidien, LLC | 2012-07-10 | Traditional | PDF ↗ |
| K112843 | PULSE OXIMETER | Nonin Medical, Inc. | 2012-04-19 | Traditional | PDF ↗ |
| K113865 | PULTOL | Sharp Corporation | 2012-03-21 | Traditional | PDF ↗ |
| K113596 | MASIMO SET REUSABLE OXIMETRY SENSORS | Masimo Corporation | 2012-02-24 | Special | PDF ↗ |
| K112804 | FINGERTIP PULSE OXIMETER | Guangdong Biolight Meditech Co., Ltd. | 2012-01-27 | Special | PDF ↗ |
| K111494 | HANDHELD PULSE OXIMETER | Beijing Choice Electronic Technololgy Co., Ltd. | 2012-01-18 | Special | PDF ↗ |
| K111403 | MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES | Masimo Corporation | 2011-12-30 | Traditional | PDF ↗ |
| K111617 | PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 | Acare Technology Co., Ltd. | 2011-12-22 | Traditional | PDF ↗ |
| K110893 | VTRUST FINGER TYPE PULSE OXIMETER | Taidoc Technology Corporation | 2011-11-22 | Traditional | PDF ↗ |
| K111621 | MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS | Masimo Corporation | 2011-10-26 | Traditional | PDF ↗ |
| K111888 | MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS | Masimo Corporation | 2011-09-23 | Special | PDF ↗ |
| K112465 | VITAL SIGNS MONITOR | Advanced Instruments, Inc. | 2011-09-14 | Traditional | PDF ↗ |
| K103802 | TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR | GE Healthcare Finland Oy | 2011-08-02 | Traditional | PDF ↗ |
| K103285 | DIXTAL DZ-4100 SERIES PULSE OXIMETER | Dixtal Medical, Inc. | 2011-07-25 | Special | PDF ↗ |
| K103685 | PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA | Beijing Rongrui-Century Scie. & Tech. Co., Ltd. | 2011-07-15 | Traditional | PDF ↗ |
| K103584 | ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS | Shenzhen Envisen Industry Co. Limited | 2011-06-10 | Traditional | PDF ↗ |
| K110028 | MASIMO RADICAL Y PULSE CO-OXIMETER | Masimo Corporation | 2011-03-17 | Special | PDF ↗ |
| K103700 | ESSENTIAL MRI PATIENT MONITOR | Invivo Corporation | 2011-03-15 | Special | PDF ↗ |
| K102270 | ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN | Envitec-Wismar GmbH | 2011-02-22 | Traditional | PDF ↗ |
| K100225 | PULSE OXIMETER MODEL P10 | Mediana Co., Ltd. | 2011-02-09 | Traditional | PDF ↗ |
| K101995 | CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD | Oridion Capnography, Inc. | 2011-01-11 | Traditional | PDF ↗ |
| K102835 | VITAL SIGNS MONITOR | Edan Instruments, Inc. | 2010-12-27 | Traditional | PDF ↗ |
| K102350 | PULSE OXIMETER | Nonin Medical, Inc. | 2010-12-22 | Traditional | PDF ↗ |
| K101012 | V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201 | Taidoc Technology Corporation | 2010-12-15 | Traditional | PDF ↗ |
| K101577 | MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-12-02 | Special | PDF ↗ |
| K101539 | VITAL SIGNS MONITOR MODEL M3B | Edan Instruments, Inc. | 2010-11-24 | Traditional | PDF ↗ |
| K101031 | MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 | Masimo Corporation | 2010-11-18 | Traditional | PDF ↗ |
| K101896 | MASIMO LNCS/M-LNCS OXIMETRY SENSORS | Masimo Corporation | 2010-10-21 | Special | PDF ↗ |
| K092641 | CHARMCARE TABLETOP PULSE OXIMETER | Charmcare Co., Ltd. | 2010-10-21 | Traditional | PDF ↗ |
| K100077 | NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 | Solaris Medical Technology, Inc. | 2010-10-07 | Traditional | PDF ↗ |
| K101871 | TRUSIGNAL SPO2 FINGERTIP SENSOR | GE Healthcare Finland Oy | 2010-10-04 | Traditional | PDF ↗ |
| K101568 | MODEL SB100II FINGER PULSE OXIMETER | Atlantean | 2010-09-20 | Traditional | PDF ↗ |
| K102442 | E.S.O. (ELECTRO SENSOR OXI) | Ld Technology, LLC | 2010-09-10 | Traditional | PDF ↗ |
| K101694 | HANDHELD PULSE OXIMETER MODEL M800 | Guangdong Biolight Meditech Co., Ltd. | 2010-09-08 | Special | PDF ↗ |
| K101600 | INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010-08-31 | Abbreviated | PDF ↗ |
| K100428 | MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER | Masimo Corporation | 2010-07-09 | Traditional | PDF ↗ |
| K100403 | MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7 | Masimo Corporation | 2010-06-23 | Traditional | PDF ↗ |
| K100815 | OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316 | Oxypulse | 2010-06-16 | Traditional | PDF ↗ |
| K093853 | SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES | Nonin Medical, Inc. | 2010-06-04 | Special | PDF ↗ |
| K100617 | MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D | Masimo Corporation | 2010-05-28 | Special | PDF ↗ |
| K100203 | HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-05-17 | Traditional | PDF ↗ |
| K094046 | LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS | Masimo Corporation | 2010-05-14 | Special | PDF ↗ |
| K093016 | VITAL SIGNS MONITOR | Shenzhen Creative Industry Co., Ltd. | 2010-03-30 | Traditional | PDF ↗ |
| K091564 | NBM-200MP PULSE OXIMETRY DEVICE | Orsense, Ltd. | 2010-03-19 | Traditional | PDF ↗ |
| K093881 | TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR | GE Healthcare Finland Oy | 2010-03-12 | Special | PDF ↗ |
| K092950 | SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES | Solaris Medical Technology, Inc. | 2010-03-12 | Special | PDF ↗ |
| K100020 | DX SERIES FINGER SENSOR | Dixtal Medical, Inc. | 2010-03-08 | Special | PDF ↗ |
| K093306 | SINGLE-PATIENT USE DISPOSABLE SENSOR | Nonin Medical, Inc. | 2010-03-04 | Special | PDF ↗ |
| K093757 | MD300C1 FINGERTIP PULSE OXIMETER | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-03-03 | Special | PDF ↗ |
| K092652 | FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA | Beijing Choice Electronic Technololgy Co., Ltd. | 2010-01-08 | Special | PDF ↗ |
| K092620 | MD300C318 FINGERTIP PULSE OXIMETER | Beijing Choice Electronic Technololgy Co., Ltd. | 2009-12-04 | Traditional | PDF ↗ |
| K092727 | H100B PULSE OXIMETER | Edan Instruments, Inc. | 2009-12-03 | Traditional | PDF ↗ |
| K092549 | OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P | Bio Medical Technologies Co., Ltd. | 2009-11-16 | Traditional | PDF ↗ |
| K091241 | MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER | Masimo Corporation | 2009-11-06 | Traditional | PDF ↗ |
| K092101 | REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES | Nonin Medical, Inc. | 2009-10-21 | Special | PDF ↗ |
| K092838 | MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 | Masimo Corporation | 2009-10-15 | Special | PDF ↗ |
| K091787 | MODEL 6000 TWO PARAMETER BEDSIDE MONITOR | Ivy Biomedical Systems, Inc. | 2009-10-09 | Traditional | PDF ↗ |
| K092678 | EVISION DATA MANAGEMENT SOFTWARE | Nonin Medical, Inc. | 2009-10-01 | Special | PDF ↗ |
| K091572 | DISPOSABLE SPO2 SENSOR M1134A | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-09-22 | Traditional | PDF ↗ |
| K092324 | SPIROPRO | Viasys Healthcare GmbH | 2009-09-03 | Special | PDF ↗ |
| K083448 | CABLE, TRANSDUCER, MODEL 2400GN | Conmed Corporation | 2009-08-20 | Traditional | PDF ↗ |
| K090662 | MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP | Masimo Corporation | 2009-08-10 | Traditional | PDF ↗ |
| K090438 | REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR | Envitec-Wismar GmbH | 2009-07-24 | Traditional | PDF ↗ |
| K090599 | MD300K1 PULSE OXIMETER | Beijing Choice Electronic Technololgy Co., Ltd. | 2009-07-20 | Traditional | PDF ↗ |
| K091057 | MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES | Masimo Corporation | 2009-07-09 | Special | PDF ↗ |
| K090165 | RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20 | Masimo Corporation | 2009-07-09 | Traditional | PDF ↗ |
| K090671 | PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D | Contec Medical System Co., Ltd. | 2009-06-11 | Traditional | PDF ↗ |
| K083010 | SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2009-06-10 | Traditional | PDF ↗ |
| K083821 | VITAL SIGNS MONITOR | Edan Instruments, Inc. | 2009-05-14 | Traditional | PDF ↗ |
| K090360 | PHILIPS M3001A MULTI MEASUREMENT SERVER | Philips Medizin Systeme Boblingen GmbH | 2009-05-04 | Special | PDF ↗ |
| K083557 | BCI WW1030 PULSE OXIMETER | Smiths Medical Pm, Inc. | 2009-05-01 | Traditional | PDF ↗ |
| K090205 | BCI WW1021 PC APPLICATION | Smiths Medical Pm, Inc. | 2009-04-28 | Traditional | PDF ↗ |
| K083351 | PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P | Comdek Industrial Corp. | 2009-04-24 | Traditional | PDF ↗ |
| K083787 | BCI WW1000 PULSE OXIMETER, MODEL WW1000 | Smiths Medical Pm, Inc. | 2009-04-15 | Traditional | PDF ↗ |
| K083705 | BCI WW1020 PULSE OXIMETER, MODEL WW1020 | Smiths Medical Pm, Inc. | 2009-04-09 | Traditional | PDF ↗ |
| K082846 | APK SPO2 PULSE OXIMETER SENSOR | APK Technology Co., Ltd. | 2009-04-03 | Traditional | PDF ↗ |
| K083466 | MD2000A VITAL SIGN MONITOR, MODEL MD2000A | Beijing Choice Electronic Technololgy Co., Ltd. | 2009-04-03 | Traditional | PDF ↗ |
| K083622 | LNCS OXIMETRY SENSORS | Masimo Corporation | 2009-04-02 | Traditional | PDF ↗ |
| K083892 | FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030) | Cas Medical Systems, Inc. | 2009-03-19 | Traditional | PDF ↗ |
| K083325 | N-600X WITH SPD, OXIMAX N-600X | Covidien | 2009-03-09 | Traditional | PDF ↗ |
| K083079 | QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 | Quanta Computer, Inc. | 2009-03-05 | Traditional | PDF ↗ |
| K082487 | M-50 SERIES SPO2 SENSOR | Beijing Choice Electronic Technololgy Co., Ltd. | 2009-03-04 | Traditional | PDF ↗ |
| K082268 | CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX | Oridion Capnography, Inc. | 2009-02-06 | Traditional | PDF ↗ |
| K081033 | MIROXI | Mir Medical Intl. Research Srl | 2009-01-15 | Traditional | PDF ↗ |
| K082789 | G1B PULSE OXIMETER | General Meditech, Inc. | 2009-01-07 | Traditional | PDF ↗ |
| K082546 | REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91) | Unimed Medical Supplies, Inc. | 2008-12-02 | Traditional | PDF ↗ |
| K082888 | INFINITY NELLCOR OXIMAX SMARTPOD, MODEL MS23997 | Draeger Medical Systems, Inc. | 2008-11-26 | Special | PDF ↗ |
| K082641 | FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL | Contec Medical System Co., Ltd. | 2008-11-10 | Special | PDF ↗ |
| K082052 | MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK | Masimo Corporation | 2008-10-10 | Traditional | PDF ↗ |
| K080348 | OXISCAN II DATA MANAGEMENT SYSTEM | Airsep Corp. | 2008-10-09 | Traditional | PDF ↗ |
| K081572 | SMARTSIGNS MINPULSE | Huntleigh Healthcare , Ltd. | 2008-10-01 | Traditional | PDF ↗ |
| K081800 | T12S TELEMETRY TRANSMITTER | Mortara Instrument, Inc. | 2008-09-24 | Abbreviated | PDF ↗ |
| K081712 | FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 | Guangdong Biolight Meditech Co., Ltd. | 2008-09-12 | Traditional | PDF ↗ |
| K081659 | RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L | Masimo Corporation | 2008-09-09 | Traditional | PDF ↗ |
| K081937 | PICOSAT II AND M3002A MULTIMEASUREMENT AND M1020B PLUG-IN MODULES SPO2 PULSE OXIMETRY MODULE | Philips Medizin Systeme Boeblingen GmbH | 2008-08-29 | Special | PDF ↗ |
| K081870 | MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO | GE Healthcare Finland Oy | 2008-07-31 | Special | PDF ↗ |
| K073249 | SOLARIS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES | Solaris Medical Technology, Inc. | 2008-07-25 | Traditional | PDF ↗ |
| K081125 | WRIST PULSE OXIMETER MD300W | Beijing Choice Electronic Technololgy Co., Ltd. | 2008-07-02 | Special | PDF ↗ |
Product code DQA · Class II · Cardiovascular. Data: openFDA.