Panels › Cardiovascular › Product code MHX · Class 2
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation 870.1025
16510(k)s in 12 months (431 all time)
41recalls in 12 months (294 all time)
277recalls that name a 510(k)
Top companies in MHX
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 1, 2004 | K040395 | CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES Nihon Kohden America, Inc. | MHX |
| Jun 1, 2004 | 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. | MHX |
| May 26, 2004 | K040246 | FUKUDA DENSHI DYNASCOPE MODEL DS-7141 PORTABLE PATIENT MONITOR Fukuda Denshi USA, Inc. | MHX |
| May 14, 2004 | K033957 | INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL Draeger Medical Systems, Inc. | MHX |
| May 12, 2004 | K041087 | INFINITY GAMMA Draeger Medical Systems, Inc. | MHX |
| May 12, 2004 | K040955 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN Philips Medical Systems, Inc. | MHX |
| Mar 22, 2004 | K033694 | INFINITY MODULAR MONITORS VF4 MODIFICATIONS Draeger Medical Systems, Inc. | MHX |
| Mar 3, 2004 | K040357 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE F.O AND THE M4840A TELEMETRY MONITORING SYSTEM II Philips Medical Systems, Inc. | MHX |
| Mar 1, 2004 | K040304 | PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50 Philips Medizin Systeme Boeblingen GmbH, DE | MHX |
| Feb 26, 2004 | K030722 | ENVOY PATIENT MONITOR Mennen Medical, Inc., IL | MHX |
| Jan 15, 2004 | K033964 | SOLAR 9500 INFORMATION MONITOR Ge Medical Systems Information Technologies | MHX |
| Dec 11, 2003 | K033600 | INFINITY GAMMAXL Draeger Medical Systems, Inc. | MHX |
| Dec 4, 2003 | K031124 | POLARIS 95000-A BEDSIDE/TRANSPORT MONITOR Datex-Ohmeda, Inc. | MHX |
| Nov 25, 2003 | K031340 | SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO Siemens Medical Solutions USA, Inc. | MHX |
| Nov 24, 2003 | K033492 | MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM Ge Medical Systems Information Technologies | MHX |
| Nov 21, 2003 | K033444 | PHILIPS MEDICAL SYSTEMS, M3012A- HEMODYNAMIC EXTENSION TO THE MULTI-MEASUREMENT SERVER Philips Medical Systems | MHX |
| Nov 12, 2003 | K033304 | MODIFICATION TO DASH 3000/4000 PATIENT MONITOR Ge Medical Systems Information Technologies | MHX |
| Nov 6, 2003 | K033365 | APEXPRO FH TELEMETRY SYSTEM Ge Medical Systems Information Technologies | MHX |
| Oct 10, 2003 | K032290 | FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR Fukuda Denshi USA, Inc. | MHX |
| Oct 10, 2003 | K031760 | VIEWPOINT TELEMETRY SYSTEM Datascope Corp. | MHX |
| Sep 9, 2003 | K031849 | SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX Datascope Corp. | MHX |
| Aug 15, 2003 | K032369 | MODIFICATION TO: APEXPRO TELEMETRY SYSTEM Ge Medical Systems Information Technologies | MHX |
| Jul 16, 2003 | K031376 | DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES Ge Medical Systems Information Technologies | MHX |
| Jun 25, 2003 | K031781 | DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES Datex-Ohmeda | MHX |
| Jun 6, 2003 | K030738 | SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM Siemens Medical Solutions USA, Inc. | MHX |
| May 30, 2003 | K031403 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1 Philips Medical Systems, Inc. | MHX |
| May 29, 2003 | K031481 | THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20 Philips Medizin Systeme Boblingen GmbH, DE | MHX |
| May 21, 2003 | K030812 | DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE Datex-Ohmeda | MHX |
| May 13, 2003 | K022834 | DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000 Ge Medical Systems Information Technologies | MHX |
| May 9, 2003 | K030931 | C3 PATIENT MONITOR Analogic Corp. | MHX |
| May 6, 2003 | K031320 | EK-PRO ARRHYTHMIA DETECTION ALGORITHM Ge Medical Systems Information Technologies | MHX |
| Apr 17, 2003 | K030613 | VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 Criticare Systems, Inc. | MHX |
| Mar 21, 2003 | K030657 | SIEMENS INFINITY GATEWAY SUITE, MODEL VF2 Siemens Medical Solutions | MHX |
| Mar 21, 2003 | K030575 | MODIFICATION TO SOLAR 9500 INFORMATION MONITOR Ge Medical Systems Information Technologies | MHX |
| Mar 12, 2003 | K030038 | PHILIPS MP60, MP70 AND MP90 INTELLIVUE PATIENT MONITORS WITH PORTAL TECHNOLOGY AND M3185 OPT C41 WIRELESS BEDSIDE ADAPTR Philips Medical Systems, Inc. | MHX |
| Mar 4, 2003 | K030105 | ANESTHESIA MONITOR; BEDSIDE MONITOR, SERIES BSM-5130A Nihon Kohden America, Inc. | MHX |
| Feb 26, 2003 | K030431 | MODIFICATION TO DASH 3000/4000 PATIENT MONITOR Ge Medical Systems Information Technologies | MHX |
| Feb 11, 2003 | K030313 | SIEMENS INFINITY SC 6002XL MODIFICATIONS Siemens Medical Solutions USA, Inc. | MHX |
| Dec 18, 2002 | K024108 | SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM Siemens Medical Solutions USA, Inc. | MHX |
| Dec 4, 2002 | K023871 | M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY Philips Medical Systems | MHX |
| Nov 29, 2002 | K023674 | PHILIPS DRUG CALCULATOR SOFTWARE Philips Medical Systems | MHX |
| Nov 19, 2002 | K023698 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O Philips Medical Systems | MHX |
| Nov 4, 2002 | K023569 | SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS Siemens Medical Solutions USA, Inc. | MHX |
| Oct 24, 2002 | K023475 | CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES Nihon Kohden America, Inc. | MHX |
| Oct 3, 2002 | K022485 | DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE02 AND L-CANE02A SOFTWARE Datex-Ohmeda | MHX |
| Sep 25, 2002 | K022889 | SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER Siemens Medical Solutions USA, Inc. | MHX |
| Aug 14, 2002 | K020290 | DASH 3000/4000 PATIENT MONITOR General Electric Medical Systems Information Techn | MHX |
| Jul 19, 2002 | K021279 | DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE Datex-Ohmeda | MHX |
| May 15, 2002 | K021422 | PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02 Philips Medical Systems | MHX |
| May 7, 2002 | K021325 | MODIFICATION OF APEXPRO TELEMETRY SYSTEM General Electric Medical Systems Information Techn | MHX |
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