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 Feb 08, 2001
ORG-9200A
K002068
Nihon Kohden America, Inc.
Cardiovascular · 216d
Cleared Jan 25, 2001
Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
K003576
Quinton, Inc.
Cardiovascular · 66d
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 Jul 18, 2000
DASH 3000/4000 PATIENT MONITOR
K001359
General Electric Medical Systems Information Techn
Cardiovascular · 81d
Cleared Jun 07, 2000
AGILENT M2636A TELEMON MONITOR
K001436
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared May 18, 2000
APEXPRO TELEMETRY SYSTEM
K000779
General Electric Medical Systems Information Techn
Cardiovascular · 69d
Cleared May 17, 2000
AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI
K001333
Agilent Technologies Deutschland GmbH
Cardiovascular · 20d
Cleared May 03, 2000
AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR
K001057
Agilent Technologies, Inc.
Cardiovascular · 30d
Cleared Apr 07, 2000
FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX
K000746
Fukuda Denshi USA, Inc.
Cardiovascular · 30d
Cleared Apr 06, 2000
AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR
K000822
Agilent Technologies, GmbH
Cardiovascular · 23d
Cleared Mar 23, 2000
SOLAR 7/8000
K993757
General Electric Medical Systems Information Techn
Cardiovascular · 139d
Cleared Mar 06, 2000
Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
K992908
Quinton, Inc.
Cardiovascular · 189d
Cleared Feb 03, 2000
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B
K993383
Hewlett-Packard GmbH
Cardiovascular · 118d
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 Nov 03, 1999
MUSE CARDIOVASCULAR INFORMATION SYSTEM
K992637
General Electric Medical Systems Information Techn
Cardiovascular · 89d
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