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
121–144 of 398
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
Cleared Feb 11, 1998
ENSEMBLE CENTRAL STATION MONITOR
K970358
Mennen Medical, Inc.
Cardiovascular · 377d
Cleared Oct 17, 1997
SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM
K972714
Siemens Medical Solutions USA, Inc.
Cardiovascular · 88d
Cleared Oct 03, 1997
FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR
K971131
Fukuda Denshi USA, Inc.
Cardiovascular · 190d
Cleared Sep 25, 1997
SPACELABS MEDICAL PCIS PATIENT MONITORS
K972282
Spacelabs Medical, Inc.
Cardiovascular · 99d
Cleared Sep 12, 1997
TELE TRENS TM 10
K960884
Life Sensing Instrument Company, Inc.
Cardiovascular · 557d
Cleared Sep 11, 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K964624
Siemens Medical Solutions USA, Inc.
Cardiovascular · 303d
Cleared Sep 09, 1997
FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR
K970585
Fukuda Denshi USA, Inc.
Cardiovascular · 207d