DSI · Class II · 21 CFR 870.1025

FDA Product Code DSI: Detector And Alarm, Arrhythmia

Leading manufacturers include Siemens Medical Solutions USA, Inc., Fukuda Denshi USA, Inc. and Nihon Kohden America, Inc..

398
Total
398
Cleared
150d
Avg days
1976
Since
398 devices
97–120 of 398
Cleared Oct 21, 1999
HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
K993171
Hewlett-Packard Co.
Cardiovascular · 30d
Cleared Jun 07, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE P
K991773
Hewlett-Packard GmbH
Cardiovascular · 13d
Cleared May 11, 1999
ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW
K990093
Agilent Technologies
Cardiovascular · 120d
Cleared Apr 19, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE T
K990972
Hewlett-Packard GmbH
Cardiovascular · 27d
Cleared Feb 16, 1999
ZYMED TELEMETRY SYSTEM, MODEL EASI VIEW
K984089
Zymed Medical Instrumentation
Cardiovascular · 92d
Cleared Jan 29, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K
K990125
Hewlett-Packard GmbH
Cardiovascular · 16d
Cleared Jan 04, 1999
HEWLETT-PACKARD M1205A VIRIDIA 24 CT
K981376
Hewlett-Packard Co.
Cardiovascular · 263d
Cleared Nov 16, 1998
CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
K980045
Invivo Research, Inc.
Cardiovascular · 314d
Cleared Nov 16, 1998
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS
K983980
Siemens Medical Solutions USA, Inc.
Cardiovascular · 7d
Cleared Nov 06, 1998
SIEMENS SC 8000 BEDSIDE MONITOR
K983632
Siemens Medical Solutions USA, Inc.
Cardiovascular · 22d
Cleared Oct 07, 1998
ZYMED TELEMETRY SYSTEM
K980186
Agilent Technologies
Cardiovascular · 260d
Cleared Sep 09, 1998
HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM)
K980429
Hewlett-Packard Co.
Cardiovascular · 217d
Cleared Aug 24, 1998
SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
K982730
Siemens Medical Solutions USA, Inc.
Cardiovascular · 39d
Cleared Aug 12, 1998
MODIFICATION TO ENSEMBLE CENTRAL STATION MONITOR
K982697
Mennen Medical, Inc.
Cardiovascular · 9d
Cleared Jul 08, 1998
SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS
K974698
Siemens Medical Solutions USA, Inc.
Cardiovascular · 204d
Cleared Jun 19, 1998
FUKUDA DENSHI DYNASCOPE MODEL DS-5000 SERIES TELEMETRY SYSTEM
K980728
Fukuda Denshi USA, Inc.
Cardiovascular · 114d
Cleared Jun 05, 1998
SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR
K980882
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared Jun 02, 1998
CS/3(TM) MONITORS*
K974792
Datex-Engstrom, Inc.
Cardiovascular · 162d
Cleared May 28, 1998
SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
K972502
Spacelabs Medical, Inc.
Cardiovascular · 329d
Cleared May 19, 1998
SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
K980625
Siemens Medical Solutions USA, Inc.
Cardiovascular · 90d
Cleared Apr 23, 1998
CS/3 ARRHYTHMIA WORKSTATION
K974747
Datex-Engstrom, Inc.
Cardiovascular · 125d
Cleared Apr 14, 1998
ENVOY PATIENT MONITOR
K974510
Mennen Medical, Inc.
Cardiovascular · 134d
Cleared Mar 23, 1998
MULTI-PARAMETER MODULE (M3000A)/DISPLAY UNIT (M3046A)
K971910
Hewlett-Packard GmbH
Cardiovascular · 304d
Cleared Feb 17, 1998
OBSERVER * CENTRAL STATION
K972498
Johnson & Johnson Medical, Inc.
Cardiovascular · 229d