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 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K040395 | CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES | Nihon Kohden America, Inc. | 2004-06-01 | Traditional | PDF ↗ |
| K040246 | FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR | Fukuda Denshi USA, Inc. | 2004-05-26 | Traditional | PDF ↗ |
| K033957 | INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL | Draeger Medical Systems, Inc. | 2004-05-14 | Special | PDF ↗ |
| K040955 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN | Philips Medical Systems, Inc. | 2004-05-12 | Special | PDF ↗ |
| K041087 | INFINITY GAMMA | Draeger Medical Systems, Inc. | 2004-05-12 | Special | PDF ↗ |
| K033694 | INFINITY MODULAR MONITORS VF4 MODIFICATIONS | Draeger Medical Systems, Inc. | 2004-03-22 | Special | PDF ↗ |
| K040357 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II | Philips Medical Systems, Inc. | 2004-03-03 | Special | PDF ↗ |
| K040304 | PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004-03-01 | Special | PDF ↗ |
| K030722 | ENVOY PATIENT MONITOR | Mennen Medical, Inc. | 2004-02-26 | Traditional | PDF ↗ |
| K033964 | SOLAR 9500 INFORMATION MONITOR | Ge Medical Systems Information Technologies | 2004-01-15 | Special | PDF ↗ |
| K033600 | INFINITY GAMMAXL | Draeger Medical Systems, Inc. | 2003-12-11 | Special | PDF ↗ |
| K031124 | POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR | Datex-Ohmeda, Inc. | 2003-12-04 | Traditional | PDF ↗ |
| K031340 | SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO | Siemens Medical Solutions USA, Inc. | 2003-11-25 | Traditional | PDF ↗ |
| K033492 | MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM | Ge Medical Systems Information Technologies | 2003-11-24 | Special | PDF ↗ |
| K033444 | PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER | Philips Medical Systems | 2003-11-21 | Special | PDF ↗ |
| K033304 | MODIFICATION TO DASH 3000/4000 PATIENT MONITOR | Ge Medical Systems Information Technologies | 2003-11-12 | Special | PDF ↗ |
| K033365 | APEXPRO FH TELEMETRY SYSTEM | Ge Medical Systems Information Technologies | 2003-11-06 | Special | PDF ↗ |
| K032290 | FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR | Fukuda Denshi USA, Inc. | 2003-10-10 | Special | PDF ↗ |
| K031760 | VIEWPOINT TELEMETRY SYSTEM | Datascope Corp. | 2003-10-10 | Abbreviated | PDF ↗ |
| K031849 | SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX | Datascope Corp. | 2003-09-09 | Abbreviated | PDF ↗ |
| K032369 | MODIFICATION TO: APEXPRO TELEMETRY SYSTEM | Ge Medical Systems Information Technologies | 2003-08-15 | Special | PDF ↗ |
| K031376 | DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES | Ge Medical Systems Information Technologies | 2003-07-16 | Special | PDF ↗ |
| K031781 | DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES | Datex-Ohmeda | 2003-06-25 | Special | PDF ↗ |
| K030738 | SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM | Siemens Medical Solutions USA, Inc. | 2003-06-06 | Traditional | PDF ↗ |
| K031403 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1 | Philips Medical Systems, Inc. | 2003-05-30 | Special | PDF ↗ |
| K031481 | THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20 | Philips Medizin Systeme Boblingen GmbH | 2003-05-29 | Special | PDF ↗ |
| K030812 | DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE | Datex-Ohmeda | 2003-05-21 | Traditional | PDF ↗ |
| K022834 | DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000 | Ge Medical Systems Information Technologies | 2003-05-13 | Traditional | PDF ↗ |
| K030931 | C3 PATIENT MONITOR | Analogic Corp. | 2003-05-09 | Special | PDF ↗ |
| K031320 | EK-PRO ARRHYTHMIA DETECTION ALGORITHM | Ge Medical Systems Information Technologies | 2003-05-06 | Special | PDF ↗ |
| K030613 | VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 | Criticare Systems, Inc. | 2003-04-17 | Special | PDF ↗ |
| K030575 | MODIFICATION TO SOLAR 9500 INFORMATION MONITOR | Ge Medical Systems Information Technologies | 2003-03-21 | Special | PDF ↗ |
| K030657 | SIEMENS INFINITY GATEWAY SUITE, MODEL VF2 | Siemens Medical Solutions | 2003-03-21 | Special | PDF ↗ |
| K030038 | PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR | Philips Medical Systems, Inc. | 2003-03-12 | Special | PDF ↗ |
| K030105 | ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A | Nihon Kohden America, Inc. | 2003-03-04 | Traditional | PDF ↗ |
| K030431 | MODIFICATION TO DASH 3000/4000 PATIENT MONITOR | Ge Medical Systems Information Technologies | 2003-02-26 | Special | PDF ↗ |
| K030313 | SIEMENS INFINITY SC 6002XL MODIFICATIONS | Siemens Medical Solutions USA, Inc. | 2003-02-11 | Special | PDF ↗ |
| K024108 | SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM | Siemens Medical Solutions USA, Inc. | 2002-12-18 | Special | PDF ↗ |
| K023871 | M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY | Philips Medical Systems | 2002-12-04 | Special | PDF ↗ |
| K023674 | PHILIPS DRUG CALCULATOR SOFTWARE | Philips Medical Systems | 2002-11-29 | Special | PDF ↗ |
| K023698 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O | Philips Medical Systems | 2002-11-19 | Special | PDF ↗ |
| K023569 | SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS | Siemens Medical Solutions USA, Inc. | 2002-11-04 | Special | PDF ↗ |
| K023475 | CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES | Nihon Kohden America, Inc. | 2002-10-24 | Special | PDF ↗ |
| K022485 | DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE | Datex-Ohmeda | 2002-10-03 | Traditional | PDF ↗ |
| K022889 | SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER | Siemens Medical Solutions USA, Inc. | 2002-09-25 | Special | PDF ↗ |
| K020290 | DASH 3000/4000 PATIENT MONITOR | General Electric Medical Systems Information Techn | 2002-08-14 | Traditional | PDF ↗ |
| K021279 | DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE | Datex-Ohmeda | 2002-07-19 | Traditional | PDF ↗ |
| K021422 | PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02 | Philips Medical Systems | 2002-05-15 | Special | PDF ↗ |
| K021325 | MODIFICATION OF APEXPRO TELEMETRY SYSTEM | General Electric Medical Systems Information Techn | 2002-05-07 | Special | PDF ↗ |
| K012226 | MONITORING SYSTEM,MODEL ARGUS PB-1000 | Schiller AG | 2002-04-08 | Traditional | PDF ↗ |
| K012915 | DINAMAP PRO 1000 MONITOR, MODEL 1000 | Ge Medical Systems Information Technologies | 2002-03-21 | Traditional | PDF ↗ |
| K020531 | PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A; PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.02, MODEL M1275B | Philips Medical Systems | 2002-03-20 | Special | PDF ↗ |
| K014261 | ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0 | Philips Medical Systems, Inc. | 2002-02-12 | Special | PDF ↗ |
| K011540 | VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07 | Datascope Corp. | 2002-02-06 | Abbreviated | PDF ↗ |
| K010923 | KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E | Siemens Elema AB | 2002-01-23 | Abbreviated | PDF ↗ |
| K014213 | SIEMENS INFINITY GATEWAY SUITE | Siemens Medical Solutions USA, Inc. | 2002-01-17 | Special | PDF ↗ |
| K013311 | MODIFICATION TO: POCKETVIEW ECG SOFTWARE | Micromedical Industries, Ltd. | 2002-01-03 | Special | PDF ↗ |
| K013624 | MODIFICATION TO AGILENT COMPONENT MONITORING SYSTEM (CMS), V24/V26 PATIENT MONITORS, BLOOD ANALYSIS PORTAL SYSTEM PLUG-I | Philips Medizin Systeme Boblingen GmbH | 2001-12-03 | Special | PDF ↗ |
| K013427 | MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A | Philips Medical Systems, Inc. | 2001-11-29 | Special | PDF ↗ |
| K013199 | PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B | Philips Medical Systems, Inc. | 2001-11-28 | Special | PDF ↗ |
| K011918 | NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES | Nihon Kohden America, Inc. | 2001-09-12 | Traditional | PDF ↗ |
| K012016 | INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II | Siemens Medical Solutions USA, Inc. | 2001-07-20 | Special | PDF ↗ |
| K011000 | TRAM 2001 MODULE | General Electric Medical Systems Information Techn | 2001-06-29 | Traditional | PDF ↗ |
| K011093 | AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 | Agilent Technologies, Inc. | 2001-05-01 | Special | PDF ↗ |
| K003243 | SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000; SC 7000; SC 9000XL | Siemens Medical Solutions USA, Inc. | 2000-12-21 | Special | PDF ↗ |
| K003248 | SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER | Siemens Medical Solutions USA, Inc. | 2000-12-21 | Special | PDF ↗ |
| K003621 | ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0 | Agilent Technologies, Inc. | 2000-12-20 | Special | PDF ↗ |
| K001433 | CNS-9300 SERIES CENTRAL STATION | Nihon Kohden America, Inc. | 2000-11-07 | Traditional | PDF ↗ |
| K001693 | LIFE SCOPE P, MODEL BSM-4100 SERIES | Nihon Kohden America, Inc. | 2000-10-24 | Traditional | PDF ↗ |
| K002478 | S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08 | Datex-Ohmeda, Inc. | 2000-10-05 | Traditional | PDF ↗ |
| K002158 | S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE | Datex-Ohmeda, Inc. | 2000-09-06 | Traditional | PDF ↗ |
| K000517 | LIFE SCOPE EC, MODEL BSM-1102 | Nihon Kohden America, Inc. | 2000-08-31 | Traditional | PDF ↗ |
| K002209 | GE MARQUETTE ECG ANALYSIS PROGRAM | General Electric Medical Systems Information Techn | 2000-08-18 | Special | PDF ↗ |
| K001268 | GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS | General Electric Medical Systems Information Techn | 2000-07-17 | Traditional | PDF ↗ |
| K001664 | COMPACT PORTABLE PATIENT MONITOR WITH WIRELESS ALAN, MODEL ALILENT M3000A/M3046A OPTION J120 | Agilent Technologies, Inc. | 2000-06-30 | Special | PDF ↗ |
| K001722 | AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE | Agilent Technologies Deutschland GmbH | 2000-06-30 | Special | PDF ↗ |
| K000815 | AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A) | Datex-Ohmeda | 2000-06-08 | Traditional | PDF ↗ |
| K000882 | DATEX-OHMEDA CS/3 TELEMETRY SYSTEM | Datex-Ohmeda | 2000-06-05 | Traditional | PDF ↗ |
| K000563 | MODIFICATION TO ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2000-05-17 | Special | PDF ↗ |
| K001348 | ST/AR ST AND ARRHYTHMIA SOFTWARE | Agilent Technologies, Inc. | 2000-05-17 | Special | PDF ↗ |
| K000168 | CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A) | Datex-Ohmeda | 2000-04-13 | Traditional | PDF ↗ |
| K993608 | DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR) | Datex-Ohmeda, Inc. | 2000-04-13 | Traditional | PDF ↗ |
| K000854 | VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER | Agilent Technologies, Inc. | 2000-04-10 | Special | PDF ↗ |
| K993974 | SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR | Siemens Medical Solutions USA, Inc. | 2000-02-22 | Traditional | PDF ↗ |
| K992273 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B | Hewlett-Packard GmbH | 2000-01-28 | Abbreviated | PDF ↗ |
| K992595 | HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH | Hewlett-Packard GmbH | 1999-12-08 | Special | PDF ↗ |
| K992929 | DASH 3000 PATIENT MONITOR | General Electric Medical Systems Information Techn | 1999-11-26 | Traditional | PDF ↗ |
| K992674 | HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A | Hewlett-Packard GmbH | 1999-11-08 | Abbreviated | PDF ↗ |
| K990476 | HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION | Hewlett-Packard GmbH | 1999-07-22 | Traditional | PDF ↗ |
| K990068 | SOLAR 9500 INFORMATION MONITOR | General Electric Medical Systems Information Techn | 1999-07-14 | Traditional | PDF ↗ |
| K983996 | SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM | Spacelabs Medical, Inc. | 1999-06-03 | Traditional | PDF ↗ |
| K990563 | SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION | Siemens Medical Solutions USA, Inc. | 1999-03-19 | Special | PDF ↗ |
| K982091 | CS/3 COMPACT AIRWAY MODULE, M-COVX | Datex-Engstrom, Inc. | 1998-12-22 | Traditional | PDF ↗ |
| K982279 | VITAL SIGNS MONITOR; ADVISOR MODEL # BCI 9200 | Bci Intl., Inc. | 1998-09-25 | Traditional | PDF ↗ |
| K980619 | SABRATEK PATIENT HOME MANAGEMENT SYSTEM | Sabratek Corp. | 1998-08-20 | Traditional | PDF ↗ |
| K980411 | NPB3900 SERIES PATIENT MONITORS | Analogic Corp. | 1998-08-20 | Traditional | PDF ↗ |
| K981576 | MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A | Hewlett-Packard GmbH | 1998-07-17 | Traditional | PDF ↗ |
| K973474 | WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS | Witt Biomedical Corporation | 1998-03-13 | Traditional | PDF ↗ |
| K971840 | OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM | Invivo Research, Inc. | 1998-03-04 | Traditional | PDF ↗ |
| K970445 | VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300 | Pace Tech Medical Monitors, Inc. | 1998-01-30 | Traditional | PDF ↗ |
Product code MHX · Class II · Cardiovascular. Data: openFDA.