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 May 19, 2008
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
K071889
Ge Healthcare
Cardiovascular · 315d
Cleared Dec 18, 2007
CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
K071995
Card Guard Scientific Survival , Ltd.
Cardiovascular · 151d
Cleared Nov 21, 2007
REVEAL XT
K071641
Medtronic, Inc.
Cardiovascular · 159d
Cleared Nov 21, 2007
REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538
K071655
Medtronic, Inc.
Cardiovascular · 156d
Cleared Nov 21, 2007
VITALOGIK MODEL 4000/4500
K073140
Mennen Medical , Ltd.
Cardiovascular · 14d
Cleared Sep 25, 2007
NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
K071805
Datascope Corp.
Cardiovascular · 85d
Cleared Mar 16, 2007
MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
K062976
Ge Medical Systems Information Technologies
Cardiovascular · 168d
Cleared Feb 23, 2007
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0
K070260
Philips Medical Systems
Cardiovascular · 28d
Cleared Apr 25, 2006
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003
K053263
Cardionet, Inc.
Cardiovascular · 154d
Cleared Dec 20, 2005
VITALOGIK
K052288
Mennen Medical , Ltd.
Cardiovascular · 119d
Cleared Dec 16, 2005
ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)
K052160
Welch Allyn, Inc.
Cardiovascular · 129d
Cleared Jun 14, 2005
LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P
K050919
Analogic Corp.
Cardiovascular · 63d
Cleared May 03, 2005
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
K050605
Spacelabs Medical, Inc.
Cardiovascular · 54d
Cleared Mar 04, 2005
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
K050175
Spacelabs Medical, Inc.
Cardiovascular · 37d
Cleared Mar 23, 2004
SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655
K024213
Siemens Medical Solutions USA, Inc.
Cardiovascular · 459d
Cleared Oct 31, 2003
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
K033305
Draeger Medical Systems, Inc.
Cardiovascular · 17d
Cleared Aug 19, 2003
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS
K031433
Siemens Medical Solutions USA, Inc.
Cardiovascular · 105d
Cleared Aug 13, 2003
CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
K032370
Ge Medical Systems Information Technologies
Cardiovascular · 12d
Cleared Dec 03, 2002
MODIFICATION TO ENVOY PATIENT MONITOR
K023798
Mennen Medical , Ltd.
Cardiovascular · 19d
Cleared Aug 28, 2002
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
K020550
Datascope Corp.
Cardiovascular · 190d
Cleared Aug 21, 2002
COSMOS SYSTEM
K013046
Spacelabs Medical, Inc.
Cardiovascular · 345d
Cleared Jul 24, 2002
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
K021376
Datex-Ohmeda
Cardiovascular · 84d
Cleared Jun 28, 2002
QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52
K021097
Spacelabs Medical, Inc.
Cardiovascular · 85d
Cleared May 08, 2002
MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
K021300
Philips Medical Systems
Cardiovascular · 14d