Detector And Alarm, Arrhythmia
FDA product code DSI · 385 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1025
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-12-09 – 2026-01-23
DSI
2026-01-23
DSI
2025-07-29
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
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DSI
2024-10-30
Zio AT® device (A100A1001)
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DSI
2023-10-06
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
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DSI
2023-08-30
SmartCardia 7L Platform
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DSI
2020-04-09
Unified Arrhythmia Diagnostic System PocketECG IV
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DSI
2020-03-26
BodyGuardian Remote Monitoring System
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DSI
2019-09-24
Patient Assistant Model PA97000
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DSI
2019-05-15
Liba3 System
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DSI
2019-03-26
MobileECG 2 BT
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DSI
2018-07-11
Medicalgorithmics Unified Cardiac Rehabilitation System
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DSI
2018-01-10
Epicardia Anywhere
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DSI
2016-07-22
Braemar Telemetry Patch System
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DSI
2016-05-25
EMMa Electronic Monitoring Management
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DSI
2016-04-22
Matrix Mini ECG Monitor
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DSI
2016-04-08
Nihon Kohden Afib Detection Program QP-039P
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DSI
2016-02-05
Vital Signs Patch System
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DSI
2016-01-15
ECG Mini System Continuous ECG Monitor and Arrhythmia Detector
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DSI
2013-02-21
MEDICAL GORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
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DSI
2012-08-10
BODYGUARDIAN SYSTEM BODYGUARDIAN CONTROL UNIT BODYGUARDIAN CONNECT
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DSI
2012-05-16
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSTIC SYSTEM
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DSI
2012-04-10
ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
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DSI
2011-11-17
INTELLIVUE MX40 PATIENT MONITOR
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DSI
2011-08-01
INTRICON DATRIX CENTAURI MT AMBULATORY PATIENT ECG TELEMETRY SYSTEM (APETS)
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DSI
2011-06-13
AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
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DSI
2011-05-04
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
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DSI
2011-04-06
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
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DSI
2011-03-03
SPACELABS MULTI-PARAMETER MODULE
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DSI
2010-12-07
MEDICAL MAGNETIC TAPE RECORDER
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DSI
2010-07-13
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
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DSI
2010-06-25
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
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DSI
2010-05-07
VITALOGIK 6000/6500
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DSI
2010-04-20
TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM
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DSI
2010-02-26
TELESENTRY, MODEL TS01
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DSI
2009-11-03
INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90
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DSI
2009-08-27
AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM
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DSI
2009-05-22
MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
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DSI
2009-05-15
EPICARDIA 5000
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DSI
2009-02-03
AVIVO MOBILE PATIENT MANAGEMENT SYSTEM
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DSI
2009-01-16
INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90
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DSI
2008-11-07
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
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DSI
2008-10-03
INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90
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DSI
2008-07-31
BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM
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DSI
2008-05-29
CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
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DSI
2008-05-19
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
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DSI
2007-12-18
CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
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DSI
2007-11-21
VITALOGIK MODEL 4000/4500
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DSI
2007-11-21
REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538
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DSI
2007-11-21
REVEAL XT; INSERTABLE CARDIAC MONITOR (MODEL 9529), PATIENT ASSISTANT (MODEL 9539)
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DSI
2007-09-25
NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX
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DSI
2007-03-16
MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER
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DSI
2007-02-23
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0
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DSI
2006-04-25
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003
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DSI
2005-12-20
VITALOGIK
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DSI
2005-12-16
ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)
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DSI
2005-06-14
LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P
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DSI
2005-05-03
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
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DSI
2005-03-04
SPACELABS MEDICAL MULTIPARAMETER MODULE 91496
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DSI
2004-03-23
SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655
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DSI
2003-10-31
INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM
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DSI
2003-10-10
THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O.
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DSI
2003-08-19
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS
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DSI
2003-08-13
CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
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DSI
2002-12-03
MODIFICATION TO ENVOY PATIENT MONITOR
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DSI
2002-08-28
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
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DSI
2002-08-21
MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM
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DSI
2002-08-21
COSMOS SYSTEM
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DSI
2002-07-24
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
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DSI
2002-06-28
QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52
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DSI
2002-05-08
MODIFICATION OF PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.03, MODEL M1275B
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DSI
2002-05-07
ST/AR ST AND ARRHYTHMIA SOFTWARE, RELEASE E.I.
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DSI
2002-02-11
SOLAR 8000M SYSTEM
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DSI
2002-02-07
CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
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DSI
2002-02-06
FUKUDA DENSHI DYNASCOPE MODEL DS-5700
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DSI
2002-02-01
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001
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DSI
2002-01-18
PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM; PHILLIPS V24/V26 PATIENT MONITOR
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DSI
2001-10-03
MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
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DSI
2001-08-20
QUEST EXERCISE STRESS SYSTEM, MODEL CONFIGURATION 14
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DSI
2001-08-17
SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
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DSI
2001-08-16
MODIFICATION TO ENVOY PATIENT MONITOR
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DSI
2001-07-02
AGILENT M2636B TELEMON B MONITOR (TELEMON B)
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DSI
2001-05-08
ENVOY PATIENT MONITOR
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DSI
2001-02-22
AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A
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DSI
2001-02-08
ORG-9200A
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DSI
2001-01-25
Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
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DSI
2000-12-21
SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
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DSI
2000-11-09
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
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DSI
2000-07-18
DASH 3000/4000 PATIENT MONITOR
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DSI
2000-06-07
AGILENT M2636A TELEMON MONITOR
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DSI
2000-05-18
APEXPRO TELEMETRY SYSTEM
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DSI
2000-05-17
AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI
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DSI
2000-05-03
AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR
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DSI
2000-04-07
FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX
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DSI
2000-04-06
AGILENTCOMPONENT MONITORING SYSTEM, AGILENT 24/26, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR
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DSI
2000-03-23
SOLAR 7/8000
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DSI
2000-03-06
Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
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DSI
2000-02-03
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B
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DSI
2000-01-13
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
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DSI
1999-11-08
HP M2600A VIRIDIA TELEMETRY SYSTEM
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DSI
1999-11-03
MUSE CARDIOVASCULAR INFORMATION SYSTEM
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