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Panels › Cardiovascular › Product code DSI · Class 2

Detector And Alarm, Arrhythmia

Regulation 870.1025

1510(k)s in 12 months (398 all time)
20recalls in 12 months (82 all time)
78recalls that name a 510(k)
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Top companies in DSI

Company510(k)sRecalls
Philips North America028
Siemens Medical Solutions USA, Inc.270
Hewlett-Packard Co.220
Fukuda Denshi USA, Inc.190
Nihon Kohden America, Inc.180
Spacelabs Healthcare, Inc.116
Spacelabs Medical, Inc.134
Oxford Medilog, Inc.140
Mennen Medical , Ltd.130
Marquette Electronics, Inc.110
Decided510(k)Device and applicantCode
Jul 18, 2000K001359DASH 3000/4000 PATIENT MONITOR
General Electric Medical Systems Information Techn
DSI
Jun 7, 2000K001436AGILENT M2636A TELEMON MONITOR
Agilent Technologies, Inc.
DSI
May 18, 2000K000779APEXPRO TELEMETRY SYSTEM
General Electric Medical Systems Information Techn
DSI
May 17, 2000K001333AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI
Agilent Technologies Deutschland GmbH, DE
DSI
May 3, 2000K001057AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR
Agilent Technologies, Inc.
DSI
Apr 7, 2000K000746FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX
Fukuda Denshi USA, Inc.
DSI
Apr 6, 2000K000822AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR
Agilent Technologies, GmbH, DE
DSI
Mar 23, 2000K993757SOLAR 7/8000
General Electric Medical Systems Information Techn
DSI
Mar 6, 2000K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
Quinton, Inc.
DSI
Feb 3, 2000K993383HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B
Hewlett-Packard GmbH, DE
DSI
Jan 13, 2000K993531PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
Datascope Corp.
DSI
Nov 8, 1999K993516HP M2600A VIRIDIA TELEMETRY SYSTEM
Hewlett-Packard Co.
DSI
Nov 3, 1999K992637MUSE CARDIOVASCULAR INFORMATION SYSTEM
General Electric Medical Systems Information Techn
DSI
Oct 21, 1999K993171HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
Hewlett-Packard Co.
DSI
Jun 7, 1999K991773HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P
Hewlett-Packard GmbH, DE
DSI
May 11, 1999K990093ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW
Agilent Technologies
DSI
Apr 19, 1999K990972HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T
Hewlett-Packard GmbH, DE
DSI
Feb 16, 1999K984089ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW
Zymed Medical Instrumentation
DSI
Jan 29, 1999K990125HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K
Hewlett-Packard GmbH, DE
DSI
Jan 4, 1999K981376HEWLETT-PACKARD M1205A VIRIDIA 24 CT
Hewlett-Packard Co.
DSI
Nov 16, 1998K983980SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS
Siemens Medical Solutions USA, Inc.
DSI
Nov 16, 1998K980045CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
Invivo Research, Inc.
DSI
Nov 6, 1998K983632SIEMENS SC 8000 BEDSIDE MONITOR
Siemens Medical Solutions USA, Inc.
DSI
Oct 7, 1998K980186ZYMED TELEMETRY SYSTEM
Agilent Technologies
DSI
Sep 9, 1998K980429HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM)
Hewlett-Packard Co.
DSI
Aug 24, 1998K982730SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
Siemens Medical Solutions USA, Inc.
DSI
Aug 12, 1998K982697MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR
Mennen Medical, Inc., IL
DSI
Jul 8, 1998K974698SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS
Siemens Medical Solutions USA, Inc.
DSI
Jun 19, 1998K980728FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM
Fukuda Denshi USA, Inc.
DSI
Jun 5, 1998K980882SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
Siemens Medical Solutions USA, Inc.
DSI
Jun 2, 1998K974792CS/3(TM) MONITORS*
Datex-Engstrom, Inc.
DSI
May 28, 1998K972502SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
Spacelabs Medical, Inc.
DSI
May 19, 1998K980625SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
Siemens Medical Solutions USA, Inc.
DSI
Apr 23, 1998K974747CS/3 ARRHYTHMIA WORKSTATION
Datex-Engstrom, Inc.
DSI
Apr 14, 1998K974510ENVOY PATIENT MONITOR
Mennen Medical, Inc., IL
DSI
Mar 23, 1998K971910MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)
Hewlett-Packard GmbH, DE
DSI
Feb 17, 1998K972498OBSERVER * CENTRAL STATION
Johnson & Johnson Medical, Inc.
DSI
Feb 11, 1998K970358ENSEMBLE CENTRAL STATION MONITOR
Mennen Medical, Inc., IL
DSI
Oct 17, 1997K972714SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM
Siemens Medical Solutions USA, Inc.
DSI
Oct 3, 1997K971131FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR
Fukuda Denshi USA, Inc.
DSI
Sep 25, 1997K972282SPACELABS MEDICAL PCIS PATIENT MONITORS
Spacelabs Medical, Inc.
DSI
Sep 12, 1997K960884TELE TRENS TM 10
Life Sensing Instrument Company, Inc.
DSI
Sep 11, 1997K964624SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
Siemens Medical Solutions USA, Inc.
DSI
Sep 9, 1997K970585FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR
Fukuda Denshi USA, Inc.
DSI
Aug 15, 1997K970348SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER
Siemens Medical Solutions USA, Inc.
DSI
Jul 29, 1997K970920SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
Siemens Medical Solutions USA, Inc.
DSI
Jun 30, 1997K964593DIASCOPE TRAVELLER PLUS (4053)
S & W Medico Teknik A/S, DK
DSI
Jun 26, 1997K970012ESCORT LINK CENTRAL STATION MONITOR
Medical Data Electronics
DSI
Jun 4, 1997K965062SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES
Siemens Medical Solutions USA, Inc.
DSI
May 15, 1997K964832HEWLETT-PACKARD CENTRALVUE SOFTWARE
Hewlett-Packard Co.
DSI

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