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
25–48 of 398
Cleared May 13, 2015
IntelliVue Patient Monitor
K150310
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 93d
Cleared Mar 12, 2015
CardiacLinx
K142352
Ross Medical Technology, Inc.
Cardiovascular · 202d
Cleared Jan 09, 2015
MENNTOR X7
K141441
Mennen Medical , Ltd.
Cardiovascular · 221d
Cleared Dec 19, 2014
VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)
K132407
Lifewatch Technologies , Ltd.
Cardiovascular · 504d
Cleared Dec 12, 2014
TELESENSE
K142180
Scottcare Corporation
Cardiovascular · 126d
Cleared May 23, 2014
CORCAM HEART MONITOR
K140548
Corcam Technologia, SA
Cardiovascular · 80d
Cleared Jan 08, 2014
V-PATCH SYSTEM
K131000
Intelesens Limited
Cardiovascular · 273d
Cleared Feb 21, 2013
MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
K124060
Medicalgorithmics S.A.
Cardiovascular · 52d
Cleared Aug 10, 2012
BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
K121197
Preventice, Inc.
Cardiovascular · 113d
Cleared May 16, 2012
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
K112921
Medicalgorithmics S.A.
Cardiovascular · 226d
Cleared Apr 10, 2012
ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
K120774
Welch Allyn, Inc.
Cardiovascular · 27d
Cleared Nov 17, 2011
INTELLIVUE MX40 PATIENT MONITOR
K113125
Philips Medical Systems
Cardiovascular · 24d
Cleared Aug 01, 2011
INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)
K111160
Intricon Datrix Corporation
Cardiovascular · 98d
Cleared Jun 13, 2011
AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
K102507
Tz Medical, Inc.
Cardiovascular · 285d
Cleared May 04, 2011
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
K103764
Medtronic, Inc.
Cardiovascular · 132d
Cleared Apr 06, 2011
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
K110499
Card Guard Scientific Survival , Ltd.
Cardiovascular · 43d
Cleared Mar 03, 2011
SPACELABS MULTI-PARAMETER MODULE
K103142
Spacelabs Healthcare, Inc.
Cardiovascular · 129d
Cleared Dec 07, 2010
MEDICAL MAGNETIC TAPE RECORDER
K102111
Wpr Medical AS
Cardiovascular · 132d
Cleared Jul 13, 2010
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
K101703
Card Guard Scientific Survival , Ltd.
Cardiovascular · 26d
Cleared Jun 25, 2010
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
K101639
Card Guard Scientific Survival , Ltd.
Cardiovascular · 15d
Cleared May 07, 2010
VITALOGIK 6000/6500
K093766
Mennen Medical , Ltd.
Cardiovascular · 151d
Cleared Apr 20, 2010
TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM
K100155
Biomedical Systems Corp.
Cardiovascular · 90d
Cleared Feb 26, 2010
TELESENTRY, MODEL TS01
K092947
Scottcare Corporation
Cardiovascular · 155d
Cleared Nov 03, 2009
INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90
K091927
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Cardiovascular · 126d