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
73–96 of 398
Cleared May 07, 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
K021251
Philips Medical Systems
Cardiovascular · 18d
Cleared Feb 11, 2002
SOLAR 8000M SYSTEM
K012467
General Electric Medical Systems Information Techn
Cardiovascular · 194d
Cleared Feb 06, 2002
FUKUDA DENSHI DYNASCOPE MODEL DS-5700
K020084
Fukuda Denshi USA, Inc.
Cardiovascular · 27d
Cleared Jan 18, 2002
PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM
K014159
Philips Medical Systems, Inc.
Cardiovascular · 30d
Cleared Oct 03, 2001
MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
K012336
Medical Data Electronics
Cardiovascular · 71d
Cleared Aug 17, 2001
SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
K012461
Siemens Medical Solutions USA, Inc.
Cardiovascular · 16d
Cleared Aug 16, 2001
MODIFICATION TO ENVOY PATIENT MONITOR
K011784
Mennen Medical , Ltd.
Cardiovascular · 69d
Cleared Jul 02, 2001
AGILENT M2636B TELEMON B MONITOR (TELEMON B)
K011824
Agilent Technologies, Inc.
Cardiovascular · 21d
Cleared May 08, 2001
ENVOY PATIENT MONITOR
K001120
Mennen Medical , Ltd.
Cardiovascular · 396d
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 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 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