FDA Product Code
FDA Product Code DSI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1025
510(k) Clearances — 398 records · page 2 of 4
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K001359 | DASH 3000/4000 PATIENT MONITOR | General Electric Medical Systems Information Techn | 2000-07-18 | Traditional | PDF ↗ |
| K001436 | AGILENT M2636A TELEMON MONITOR | Agilent Technologies, Inc. | 2000-06-07 | Special | PDF ↗ |
| K000779 | APEXPRO TELEMETRY SYSTEM | General Electric Medical Systems Information Techn | 2000-05-18 | Traditional | PDF ↗ |
| K001333 | AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI | Agilent Technologies Deutschland GmbH | 2000-05-17 | Special | PDF ↗ |
| K001057 | AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR | Agilent Technologies, Inc. | 2000-05-03 | Special | PDF ↗ |
| K000746 | FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX | Fukuda Denshi USA, Inc. | 2000-04-07 | Special | PDF ↗ |
| K000822 | AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR | Agilent Technologies, GmbH | 2000-04-06 | Special | PDF ↗ |
| K993757 | SOLAR 7/8000 | General Electric Medical Systems Information Techn | 2000-03-23 | Traditional | PDF ↗ |
| K992908 | Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) | Quinton, Inc. | 2000-03-06 | Traditional | PDF ↗ |
| K993383 | HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B | Hewlett-Packard GmbH | 2000-02-03 | Abbreviated | PDF ↗ |
| K993531 | PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX | Datascope Corp. | 2000-01-13 | Abbreviated | PDF ↗ |
| K993516 | HP M2600A VIRIDIA TELEMETRY SYSTEM | Hewlett-Packard Co. | 1999-11-08 | Special | PDF ↗ |
| K992637 | MUSE CARDIOVASCULAR INFORMATION SYSTEM | General Electric Medical Systems Information Techn | 1999-11-03 | Traditional | PDF ↗ |
| K993171 | HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A | Hewlett-Packard Co. | 1999-10-21 | Special | PDF ↗ |
| K991773 | HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P | Hewlett-Packard GmbH | 1999-06-07 | Special | PDF ↗ |
| K990093 | ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW | Agilent Technologies | 1999-05-11 | Traditional | PDF ↗ |
| K990972 | HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T | Hewlett-Packard GmbH | 1999-04-19 | Special | PDF ↗ |
| K984089 | ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW | Zymed Medical Instrumentation | 1999-02-16 | Traditional | PDF ↗ |
| K990125 | HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K | Hewlett-Packard GmbH | 1999-01-29 | Special | PDF ↗ |
| K981376 | HEWLETT-PACKARD M1205A VIRIDIA 24 CT | Hewlett-Packard Co. | 1999-01-04 | Traditional | PDF ↗ |
| K980045 | CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM | Invivo Research, Inc. | 1998-11-16 | Traditional | PDF ↗ |
| K983980 | SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS | Siemens Medical Solutions USA, Inc. | 1998-11-16 | Special | PDF ↗ |
| K983632 | SIEMENS SC 8000 BEDSIDE MONITOR | Siemens Medical Solutions USA, Inc. | 1998-11-06 | Special | PDF ↗ |
| K980186 | ZYMED TELEMETRY SYSTEM | Agilent Technologies | 1998-10-07 | Traditional | PDF ↗ |
| K980429 | HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM) | Hewlett-Packard Co. | 1998-09-09 | Traditional | PDF ↗ |
| K982730 | SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR | Siemens Medical Solutions USA, Inc. | 1998-08-24 | Traditional | PDF ↗ |
| K982697 | MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR | Mennen Medical, Inc. | 1998-08-12 | Special | PDF ↗ |
| K974698 | SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS | Siemens Medical Solutions USA, Inc. | 1998-07-08 | Traditional | PDF ↗ |
| K980728 | FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM | Fukuda Denshi USA, Inc. | 1998-06-19 | Traditional | PDF ↗ |
| K980882 | SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR | Siemens Medical Solutions USA, Inc. | 1998-06-05 | Traditional | PDF ↗ |
| K974792 | CS/3(TM) MONITORS* | Datex-Engstrom, Inc. | 1998-06-02 | Traditional | PDF ↗ |
| K972502 | SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496 | Spacelabs Medical, Inc. | 1998-05-28 | Traditional | PDF ↗ |
| K980625 | SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG) | Siemens Medical Solutions USA, Inc. | 1998-05-19 | Traditional | PDF ↗ |
| K974747 | CS/3 ARRHYTHMIA WORKSTATION | Datex-Engstrom, Inc. | 1998-04-23 | Traditional | PDF ↗ |
| K974510 | ENVOY PATIENT MONITOR | Mennen Medical, Inc. | 1998-04-14 | Traditional | PDF ↗ |
| K971910 | MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A) | Hewlett-Packard GmbH | 1998-03-23 | Traditional | PDF ↗ |
| K972498 | OBSERVER * CENTRAL STATION | Johnson & Johnson Medical, Inc. | 1998-02-17 | Traditional | PDF ↗ |
| K970358 | ENSEMBLE CENTRAL STATION MONITOR | Mennen Medical, Inc. | 1998-02-11 | Traditional | PDF ↗ |
| K972714 | SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM | Siemens Medical Solutions USA, Inc. | 1997-10-17 | Traditional | PDF ↗ |
| K971131 | FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR | Fukuda Denshi USA, Inc. | 1997-10-03 | Traditional | PDF ↗ |
| K972282 | SPACELABS MEDICAL PCIS PATIENT MONITORS | Spacelabs Medical, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K960884 | TELE TRENS TM 10 | Life Sensing Instrument Company, Inc. | 1997-09-12 | Traditional | PDF ↗ |
| K964624 | SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM | Siemens Medical Solutions USA, Inc. | 1997-09-11 | Traditional | PDF ↗ |
| K970585 | FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR | Fukuda Denshi USA, Inc. | 1997-09-09 | Traditional | PDF ↗ |
| K970348 | SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER | Siemens Medical Solutions USA, Inc. | 1997-08-15 | Traditional | PDF ↗ |
| K970920 | SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM | Siemens Medical Solutions USA, Inc. | 1997-07-29 | Traditional | PDF ↗ |
| K964593 | DIASCOPE TRAVELLER PLUS (4053) | S & W Medico Teknik A/S | 1997-06-30 | Traditional | PDF ↗ |
| K970012 | ESCORT LINK CENTRAL STATION MONITOR | Medical Data Electronics | 1997-06-26 | Traditional | PDF ↗ |
| K965062 | SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES | Siemens Medical Solutions USA, Inc. | 1997-06-04 | Traditional | PDF ↗ |
| K964832 | HEWLETT-PACKARD CENTRALVUE SOFTWARE | Hewlett-Packard Co. | 1997-05-15 | Traditional | PDF ↗ |
| K970545 | DASH 1000 PATIENT MONITOR | Marquette Medical Systems, Inc. | 1997-05-08 | Traditional | PDF ↗ |
| K964187 | FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR | Fukuda Denshi USA, Inc. | 1997-05-01 | Traditional | PDF ↗ |
| K952912 | SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULE | Spacelabs Medical, Inc. | 1997-04-02 | Traditional | PDF ↗ |
| K962970 | SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION | Spacelabs Medical, Inc. | 1997-03-25 | Traditional | PDF ↗ |
| K963057 | FUKUDA DENSHI MODEL LX-3240 ECG & RESPIRATORY TRANSMITTER | Fukuda Denshi USA, Inc. | 1997-03-21 | Traditional | PDF ↗ |
| K962827 | ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU) | Marquette Electronics, Inc. | 1997-02-24 | Traditional | PDF ↗ |
| K962291 | SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM | Siemens Medical Solutions USA, Inc. | 1997-01-29 | Traditional | PDF ↗ |
| K955023 | BRENTWOOD PC-ECG | Brentwood Medical Products, Inc. | 1997-01-22 | Traditional | PDF ↗ |
| K962404 | SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM | Siemens Medical Solutions USA, Inc. | 1997-01-17 | Traditional | PDF ↗ |
| K964122 | HP STAR ST AND ARRHHYTHMIA SOFTWARE | Hewlett-Packard Co. | 1997-01-08 | Traditional | PDF ↗ |
| K961165 | HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A | Hewlett-Packard Co. | 1996-10-10 | Traditional | PDF ↗ |
| K960418 | EAGLE PATIENT MONITOR | Marquette Electronics, Inc. | 1996-10-02 | Traditional | PDF ↗ |
| K961139 | EAGLE PATIENT MONITOR MODEL 3000/3100 | Marquette Electronics, Inc. | 1996-08-09 | Traditional | PDF ↗ |
| K955743 | SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM | Siemens Medical Solutions USA, Inc. | 1996-07-08 | Traditional | PDF ↗ |
| K952054 | SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960) | Siemens Medical Solutions USA, Inc. | 1996-06-07 | Traditional | PDF ↗ |
| K955059 | OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER | Siemens Medical Solutions USA, Inc. | 1996-06-07 | Traditional | PDF ↗ |
| K954852 | SOLAR 9000 ANESTHESIA INFORMATION MONITOR | Marquette Electronics, Inc. | 1996-05-29 | Traditional | PDF ↗ |
| K952417 | QUEST EXERCISE STRESS SYSTEM | Burdick, Inc. | 1996-05-22 | Traditional | PDF ↗ |
| K935732 | CARDIO PERFECT ST 2001 | Cardio Control BV | 1996-04-04 | Traditional | PDF ↗ |
| K945944 | NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM | Nihon Kohden America, Inc. | 1995-11-27 | Traditional | PDF ↗ |
| K951370 | ZYMED TELEMETRY SYSTEM; MODEL T8010 | Zymed Medical Instrumentation | 1995-10-06 | Traditional | PDF ↗ |
| K951371 | 1481 T DIGITAL TELEMETRY SYSTEM WITH S-T SEGMENT ANALYSIS OPTION | Siemens Medical Solutions USA, Inc. | 1995-10-04 | Traditional | PDF ↗ |
| K950821 | HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24 | Hewlett-Packard Co. | 1995-10-03 | Traditional | PDF ↗ |
| K952885 | SINGLE LEAD DIGITAL TELEMETRY TRANSMITTER | Spacelabs Medical, Inc. | 1995-09-26 | Traditional | PDF ↗ |
| K945429 | SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352) | Spacelabs Medical, Inc. | 1995-08-15 | Traditional | PDF ↗ |
| K942196 | 3050 DIASCOPE NT PATIENT MONITOR | S & W Medico Teknik A/S | 1995-06-28 | Traditional | PDF ↗ |
| K946306 | SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM | Siemens Medical Solutions USA, Inc. | 1995-06-27 | Traditional | PDF ↗ |
| K935877 | NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A | Nihon Kohden America, Inc. | 1995-05-24 | Traditional | PDF ↗ |
| K944422 | BSM-8800A BEDSIDE MONITOR | Nihon Kohden America, Inc. | 1995-05-24 | Traditional | PDF ↗ |
| K942058 | SPACELABS MEDICAL ECG MODULE (MODEL 90492) | Spacelabs Medical, Inc. | 1995-05-17 | Traditional | PDF ↗ |
| K945384 | 1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED | Siemens Medical Solutions USA, Inc. | 1995-05-10 | Traditional | PDF ↗ |
| K933177 | SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS | Siemens Medical Solutions USA, Inc. | 1995-04-10 | Traditional | PDF ↗ |
| K944350 | SC 6000/ SC 6000P/ R50 | Siemens Medical Solutions USA, Inc. | 1995-04-10 | Traditional | PDF ↗ |
| K942147 | PACIFIC COMMUNICATIONS MODEL 1100 | Accucore, Inc. | 1995-01-30 | Traditional | PDF ↗ |
| K935846 | MODEL ACUITY CENTRAL STATION | Protocol Systems, Inc. | 1994-12-05 | Traditional | PDF ↗ |
| K925510 | MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING | Spacelabs Medical, Inc. | 1994-10-27 | Traditional | PDF ↗ |
| K920790 | MARQUETTE EAGLE MONITOR | Marquette Electronics, Inc. | 1994-04-19 | Traditional | PDF ↗ |
| K931716 | BATTERY PACK 1017LA | Portable Power Systems, Inc. | 1994-02-07 | Traditional | PDF ↗ |
| K930095 | SPACELABS MEDICAL PATIENT MONITOR | Spacelabs Medical, Inc. | 1993-09-03 | Traditional | PDF ↗ |
| K923747 | CC ARHYTHMIS MONITORING OPTION | Hewlett-Packard Co. | 1993-07-20 | Traditional | PDF ↗ |
| K925411 | MODEL 2041-PC/ST CARDIAC TELEMETRY MONITOR | Accucore, Inc. | 1993-02-25 | Traditional | PDF ↗ |
| K922027 | AMBULATORY (HOLTER) RECORDING, MODIFICATION | Biosensor Corp. | 1993-02-17 | Traditional | PDF ↗ |
| K920154 | BSM-8800A BEDSIDE MONITOR | Nihon Kohden America, Inc. | 1992-12-18 | Traditional | PDF ↗ |
| K924672 | ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY) | Agilent Technologies | 1992-12-15 | Traditional | PDF ↗ |
| K920743 | DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS | Nihon Kohden America, Inc. | 1992-09-03 | Traditional | PDF ↗ |
| K914092 | BSM-2100A CONFIGURED PATIENT MONITOR | Nihon Kohden America, Inc. | 1992-05-28 | Traditional | PDF ↗ |
| K913117 | ZB-860PA MULTIPARAMETER TRANSMITTER | Nihon Kohden America, Inc. | 1992-04-29 | Traditional | PDF ↗ |
| K915153 | ESCORT-LINK ARRHYTHMIA OPTION 23L | Medical Data Electronics | 1992-04-27 | Traditional | PDF ↗ |
| K910929 | OHMEDA MODULUS CD ANESTHESIA SYSTEM WITH C.V. | Ohmeda Medical | 1992-03-19 | Traditional | PDF ↗ |
| K911835 | RAPSODY(TM) REAL-TIME ARRHYTHMIA PROCESSING SYSTEM | Gs Microsystems | 1992-02-14 | Traditional | PDF ↗ |
Product code DSI · Class II · Cardiovascular. Data: openFDA.