FDA Product Code
FDA Product Code MHX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1025
510(k) Clearances — 430 records · page 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K101067 | SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068 | Philips Medical Systems | 2010-05-07 | Special | PDF ↗ |
| K100939 | INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2010-04-30 | Special | PDF ↗ |
| K100046 | M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 | Guangdong Biolight Meditech Co., Ltd. | 2010-04-08 | Traditional | PDF ↗ |
| K093788 | INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION | Draeger Medical Systems, Inc. | 2010-03-08 | Traditional | PDF ↗ |
| K092369 | 12SL ECG ANALYSIS PROGRAM | Ge Medical Systems Information Technologies | 2010-02-24 | Traditional | PDF ↗ |
| K092970 | GENERAL PATIENT MONITORS, MODELS: G3C/ G3D/ G3F/ G3G/ G3H | General Meditech, Inc. | 2010-02-02 | Traditional | PDF ↗ |
| K093501 | ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION | Spacelabs Medical, Inc. | 2009-11-24 | Special | PDF ↗ |
| K092680 | DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN | GE Healthcare Finland Oy | 2009-09-23 | Special | PDF ↗ |
| K092027 | CARESCAPE MONITOR B850 | Ge Medical Systems Information Technologies | 2009-08-28 | Traditional | PDF ↗ |
| K091594 | HEART-EXERCISE | Ge Medical Systems Information Technologies GmbH | 2009-07-29 | Traditional | PDF ↗ |
| K091834 | PASSPORT V MONITOR, MODEL 0998-00-6100 | Datascope Corp., Patient Monitoring Division | 2009-07-15 | Special | PDF ↗ |
| K091395 | MP5 INTELLIVUE PATIENT MONITOR | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-06-05 | Special | PDF ↗ |
| K090443 | PLANET 55, MODEL 100 | Larsen & Toubro Limited | 2009-06-05 | Traditional | PDF ↗ |
| K090172 | STAR 55 MODEL 100 | Larsen & Toubro Limited | 2009-06-05 | Traditional | PDF ↗ |
| K090556 | SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE | Spacelabs Healthcare Medical Equipment (Suzhou) CO | 2009-04-30 | Traditional | PDF ↗ |
| K090702 | MODIFICATION TO DASH 2500 PATIENT MONITOR | Ge Medical Systems Information Technologies | 2009-04-15 | Special | PDF ↗ |
| K083750 | CAPNOSTAT / CAPNOFLEX CO2 SYSTEM | Ge Medical Systems Information Technologies | 2009-03-23 | Special | PDF ↗ |
| K083697 | FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M | Fukuda Denshi USA, Inc. | 2009-03-19 | Traditional | PDF ↗ |
| K082583 | INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5 | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009-02-25 | Special | PDF ↗ |
| K083271 | BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY | Nihon Kohden America, Inc. | 2008-12-24 | Special | PDF ↗ |
| K082785 | NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES | Nihon Kohden America, Inc. | 2008-11-26 | Special | PDF ↗ |
| K083228 | PHILIPS INTELLIVUE MP5 PATIENT MONITOR | Philips Medizin Systeme Boblingen GmbH | 2008-11-24 | Special | PDF ↗ |
| K081793 | PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A INTELLIVUE TELEMETRY SYSTEM TRANSCEIVER | Philips Medizin Systeme Boeblingen GmbH | 2008-10-14 | Special | PDF ↗ |
| K082280 | SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR | Philips Medical Systems North America Co. | 2008-10-08 | Special | PDF ↗ |
| K081891 | FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR | Fukuda Denshi USA, Inc. | 2008-08-29 | Traditional | PDF ↗ |
| K081983 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 | Philips Medical Systems | 2008-08-22 | Special | PDF ↗ |
| K082045 | MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 | Spacelabs Medical, Inc. | 2008-08-01 | Special | PDF ↗ |
| K081140 | VISENSIA | Obs Medical | 2008-07-17 | Traditional | PDF ↗ |
| K073280 | BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5 | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008-06-23 | Traditional | PDF ↗ |
| K080251 | APEXPRO TELEMETRY SYSTEMS | Ge Medical Systems Information Technologies | 2008-06-20 | Traditional | PDF ↗ |
| K073550 | PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION | Nihon Kohden America, Inc. | 2008-03-28 | Special | PDF ↗ |
| K080495 | SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3 | Philips Medical Systems | 2008-03-24 | Special | PDF ↗ |
| K080157 | DASH 2500 PATIENT MONITOR | Ge Medical Systems Information Technologies | 2008-03-24 | Traditional | PDF ↗ |
| K080342 | NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES | Nihon Kohden America, Inc. | 2008-02-26 | Special | PDF ↗ |
| K073462 | MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES | Ge Medical Systems Information Technologies | 2008-01-11 | Special | PDF ↗ |
| K071164 | LIFE+CEL BATTERY | Amco International Manufacturing & Design, Inc. | 2007-12-07 | Traditional | PDF ↗ |
| K072346 | PM-7000 PATIENT MONITOR | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-11-29 | Special | PDF ↗ |
| K073203 | CARESCAPE V100 | Ge Medical Systems Information Technologies | 2007-11-29 | Special | PDF ↗ |
| K072070 | PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007-08-10 | Special | PDF ↗ |
| K070791 | PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-06-26 | Traditional | PDF ↗ |
| K071020 | DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE | GE Healthcare | 2007-06-18 | Special | PDF ↗ |
| K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, AND MP90 INTELLIVUE PATIENT MONITORS | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007-06-13 | Special | PDF ↗ |
| K070566 | INFINITY DELTA/DELTA XL/ KAPPA/ GAMMA X XL/ VISTA XL/ SC7000/SC8000/ SC9000XL | Draeger Medical Systems, Inc. | 2007-06-04 | Special | PDF ↗ |
| K071073 | SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE | Ge Medical Systems Information Technologies | 2007-05-11 | Special | PDF ↗ |
| K063690 | COLIN PRESS MATE, MODEL BP S510 | Omron Healthcare, Inc. | 2007-05-09 | Special | PDF ↗ |
| K062194 | HYPERVISOR VI CENTRAL MONITORING SYSTEM | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2007-04-11 | Traditional | PDF ↗ |
| K070588 | PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER) | Philips Medical Systems | 2007-03-20 | Special | PDF ↗ |
| K061379 | INFINITY TELESMART TELEMETRY SYSTEM | Draeger Medical Systems, Inc. | 2007-02-16 | Traditional | PDF ↗ |
| K063725 | MP5 INTELLIVUE PATIENT MONITOR | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007-02-08 | Traditional | PDF ↗ |
| K062098 | SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX | Datascope Corp. | 2007-02-05 | Abbreviated | PDF ↗ |
| K062324 | MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN | GE Healthcare | 2006-12-06 | Traditional | PDF ↗ |
| K062271 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) | Philips Medical Systems | 2006-11-30 | Special | PDF ↗ |
| K063315 | INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 | Philips Medizin Systeme Boeblingen GmbH | 2006-11-20 | Special | PDF ↗ |
| K061993 | EQUIVITAL, MODEL EQ-01 | Hidalgo Limited | 2006-11-03 | Traditional | PDF ↗ |
| K062144 | ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810 | Invivo Corporation | 2006-10-12 | Traditional | PDF ↗ |
| K062095 | MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 | Spacelabs Medical, Inc. | 2006-09-29 | Abbreviated | PDF ↗ |
| K062576 | DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES | GE Healthcare | 2006-09-29 | Special | PDF ↗ |
| K062283 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS | Philips Medical Systems North America, Inc. | 2006-09-20 | Special | PDF ↗ |
| K062392 | PHILIPS MP5 INTELLIVUE PATIENT MONITOR | Philips Medizin Systeme Boeblingen GmbH | 2006-09-06 | Special | PDF ↗ |
| K061610 | PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS | Philips Medizin Systeme Boeblingen GmbH | 2006-08-14 | Special | PDF ↗ |
| K061675 | VISION VXC CENTRAL STATION, MODEL 4300 | Invivo Corporation | 2006-08-02 | Special | PDF ↗ |
| K060833 | 12SL ECG ANALYSIS PROGRAM | Ge Medical Systems Information Technologies | 2006-08-01 | Special | PDF ↗ |
| K060281 | VS-800 VITAL SIGNS MONITOR | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2006-06-23 | Traditional | PDF ↗ |
| K061052 | THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 | Philips Medical Systems North America, Inc. | 2006-05-26 | Special | PDF ↗ |
| K053207 | ARGUS, MODEL LCM | Schiller AG | 2006-05-19 | Traditional | PDF ↗ |
| K060135 | MORTARA SURVEYOR TELEMETRY CENTRAL STATION | Mortara Instrument, Inc. | 2006-05-15 | Abbreviated | PDF ↗ |
| K061185 | DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE | GE Healthcare | 2006-05-15 | Special | PDF ↗ |
| K060039 | INFINITY DELTA AND KAPPA SERIES MONITORS WITH VF6 MODIFICATIONS | Draeger Medical Systems, Inc. | 2006-04-12 | Special | PDF ↗ |
| K060223 | INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM | Draeger Medical Systems, Inc. | 2006-04-12 | Special | PDF ↗ |
| K053121 | TRAM MODULE | GE Healthcare | 2006-04-05 | Special | PDF ↗ |
| K060541 | THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS | Philips Medizin Systeme Boblingen GmbH | 2006-03-24 | Special | PDF ↗ |
| K053484 | INFINITY GAMMA / GAMMAXL, INFINITY VISTA | Draeger Medical Systems, Inc. | 2006-02-22 | Special | PDF ↗ |
| K060221 | THE PHILLIPS, MODEL MP20,MP30,MP40,MP50,MP60,MP70,MP80,AND MP90 INTELLIVUE PATIENT MONITORS | Philips Medizin Systeme Boeblingen GmbH | 2006-02-17 | Special | PDF ↗ |
| K051217 | DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P) | GE Healthcare | 2006-02-03 | Special | PDF ↗ |
| K051400 | DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS | GE Healthcare | 2006-01-20 | Special | PDF ↗ |
| K053522 | PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00 | Philips Medizin Systeme Boeblingen GmbH | 2006-01-10 | Special | PDF ↗ |
| K051658 | INFINITY ALPHA | Draeger Medical Systems, Inc. | 2005-11-16 | Traditional | PDF ↗ |
| K052801 | INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 | Philips Medizin Systeme Boeblingen GmbH | 2005-11-02 | Special | PDF ↗ |
| K052756 | DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM | GE Healthcare | 2005-11-01 | Special | PDF ↗ |
| K052707 | M3046B COMPACT PORTABLE PATIENT MONITORS | Philips Medical Systems | 2005-10-20 | Special | PDF ↗ |
| K051628 | INFINITY MONITORS WITH SCIO MODIFICATIONS | Draeger Medical Systems, Inc. | 2005-07-20 | Special | PDF ↗ |
| K051367 | PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000 | Ge Medical Systems Information Technologies | 2005-06-20 | Special | PDF ↗ |
| K050762 | PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 | Philips Medizin Systeme Boeblingen GmbH | 2005-04-22 | Special | PDF ↗ |
| K050742 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00 | Philips Medical Systems | 2005-04-05 | Special | PDF ↗ |
| K043551 | DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES | Datex-Ohmeda | 2005-02-18 | Traditional | PDF ↗ |
| K042904 | INFINITY KAPPA XLT | Draeger Medical Systems, Inc. | 2005-02-18 | Traditional | PDF ↗ |
| K043439 | INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL | Draeger Medical Systems, Inc. | 2005-02-18 | Traditional | PDF ↗ |
| K050141 | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS | Philips Medizin Systeme Boeblingen GmbH | 2005-02-11 | Special | PDF ↗ |
| K043549 | INFINITY GATEWAY SUITE, VF4 | Draeger Medical Systems, Inc. | 2005-01-21 | Special | PDF ↗ |
| K043276 | DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE | Datex-Ohmeda | 2004-12-23 | Traditional | PDF ↗ |
| K042642 | AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR) | Ge Medical Systems Information Technologies | 2004-11-03 | Traditional | PDF ↗ |
| K042656 | INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 | Draeger Medical Systems, Inc. | 2004-10-06 | Special | PDF ↗ |
| K041772 | DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES | Datex-Ohmeda | 2004-07-28 | Special | PDF ↗ |
| K041790 | DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE | Datex-Ohmeda | 2004-07-23 | Traditional | PDF ↗ |
| K041741 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.0 AND M4840A PHILIPS TELEMETRY SYSTEM II INCLUDING M4841A PATIEN | Philips Medical Systems, Inc. | 2004-07-21 | Special | PDF ↗ |
| K041607 | QUINTON Q-TE; RMS | Quinton Cardiology, Inc. | 2004-07-16 | Abbreviated | PDF ↗ |
| K041235 | PHILIPS MP20, MP30, MP40, MP50. MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS | Philips Medizin Systeme Boeblingen GmbH | 2004-06-04 | Special | PDF ↗ |
| K040458 | MODIFICATION TO DASH 3000/4000 PATIENT MONITOR | Ge Medical Systems Information Technologies | 2004-06-03 | Special | PDF ↗ |
| K033711 | FUKUDA DENSHI DYNASCOPE MODEL DS-5000 CENTRAL TELEMETRY SYSTEM | Fukuda Denshi USA, Inc. | 2004-06-03 | Special | PDF ↗ |
| K033048 | CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS | Cas Medical Systems, Inc. | 2004-06-01 | Special | PDF ↗ |
Product code MHX · Class II · Cardiovascular. Data: openFDA.