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
49–72 of 398
Cleared Dec 21, 2000
SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
K003246
Siemens Medical Solutions USA, Inc.
Cardiovascular · 65d
Cleared Nov 09, 2000
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K003179
Siemens Medical Solutions USA, Inc.
Cardiovascular · 29d
Cleared Apr 07, 2000
FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX
K000746
Fukuda Denshi USA, Inc.
Cardiovascular · 30d
Cleared Mar 06, 2000
Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
K992908
Quinton, Inc.
Cardiovascular · 189d
Cleared Jan 13, 2000
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
K993531
Datascope Corp.
Cardiovascular · 87d
Cleared Nov 08, 1999
HP M2600A VIRIDIA TELEMETRY SYSTEM
K993516
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Oct 21, 1999
HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A
K993171
Hewlett-Packard Co.
Cardiovascular · 30d
Cleared Jan 04, 1999
HEWLETT-PACKARD M1205A VIRIDIA 24 CT
K981376
Hewlett-Packard Co.
Cardiovascular · 263d
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 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 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 14, 1998
ENVOY PATIENT MONITOR
K974510
Mennen Medical, Inc.
Cardiovascular · 134d
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