Transmitters And Receivers, Electrocardiograph, Telephone
FDA product code DXH · 287 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.2920
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-09-10 – 2026-02-13
DXH
2026-02-13
DXH
2025-12-08
HeartBeam AIMIGo with 12-L ECG Synthesis Software System
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DXH
2025-12-05
MEMO Patch M (MPT-E08R-UNC01)
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DXH
2025-11-18
Hexoskin Medical System (7100-00016)
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DXH
2025-06-17
VitalSigns 1-Lead Holter (VSH101)
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DXH
2023-12-06
QT ECG (QTERD100)
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DXH
2022-10-20
V-Patch Cardiac Monitor
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DXH
2022-09-26
QT ECG
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DXH
2022-07-19
Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
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DXH
2022-05-25
KardiaMobile 6L
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DXH
2021-11-30
KardiaMobile Card
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DXH
2021-09-22
SimpleSENSE Platform
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DXH
2021-06-30
KardiaMobile 6L
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DXH
2020-11-06
SimpleSENSE
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DXH
2020-10-30
eCordum Cardiac Monitor (eCordum CM)
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DXH
2020-09-23
Halo AF Detection System
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DXH
2020-01-24
KardiaMobile, KardiaStation
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DXH
2020-01-17
Study Watch with Irregular Pulse Monitor
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DXH
2019-05-10
Triangle System
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DXH
2019-04-12
KardiaMobile, KardiaStation
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DXH
2019-02-22
HeartCheck Cardi Beat ECG Monitor with GEMS Mobile
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DXH
2019-02-16
RX-1 Rhythm Express Remote Cardiac Monitoring System
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DXH
2019-02-08
Coala Heart Monitor
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DXH
2019-01-17
Study Watch
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DXH
2018-11-30
Prizma
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DXH
2018-09-28
FibriCheck
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DXH
2018-08-11
CARDIOSKIN
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DXH
2018-05-04
QT ECG
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DXH
2017-12-15
BioFlux Device
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DXH
2017-11-16
Kardia Band System
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DXH
2017-10-18
ECG SENTINEL System
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DXH
2017-10-02
ECG Check - Universal, ECG Check - Universal Plus
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DXH
2017-09-01
Prizma
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DXH
2016-11-30
SimplECG
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DXH
2013-11-26
EMOTION ECG MOBILE
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DXH
2013-06-25
EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)
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DXH
2013-02-14
ECG CHECK
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DXH
2012-02-22
SMARTHEART
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DXH
2010-04-20
VITAPHONE. MODEL 100 BT
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DXH
2010-03-25
RAISIN PERSONAL MONITOR
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DXH
2009-12-17
HEALTHEPOD
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DXH
2009-04-23
CLUE MEDICAL AND CLUE MEDICAL BASIC
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DXH
2008-12-15
HEARTRAK SMART ECAT
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DXH
2008-10-10
TEMPUSIC PATIENT MONITOR
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DXH
2008-09-02
BT3/6, BT12
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DXH
2008-07-11
CARDIOSEN'C
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DXH
2008-06-24
ECARD AND CCARD
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DXH
2008-05-14
HEARTRAK AF
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DXH
2008-01-11
HEARTEVENT, MODEL AT
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DXH
2007-11-21
FIDELITY 200 CARDIAC EVENT RECORDER
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DXH
2007-09-12
RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
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DXH
2007-01-25
SENTINEL
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DXH
2006-09-15
TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +
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DXH
2006-08-22
CG-6108 ARRHYTHMIA ECG EVENT RECORDER
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DXH
2006-08-02
PEPER
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DXH
2006-07-21
PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES
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DXH
2006-06-23
AFIBALERT ATRIAL FIBRILLATION DETECTOR
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DXH
2006-02-23
LOOP RECORDER VITAPHONE, 3100 SERIES
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DXH
2006-01-09
CG-7000DX-BT ECG RECORDER/TRANSMITTER
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DXH
2005-10-07
VITALCAREGIVING SYSTEM
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DXH
2005-08-19
CARDIONAVIGATOR +
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DXH
2005-07-19
MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370
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DXH
2005-07-01
PMP4 MEDICAL WEB CENTER
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DXH
2005-03-30
SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS
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DXH
2005-01-13
PMP4 SELFCHECK ECG
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DXH
2004-09-15
VST3
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DXH
2004-08-12
E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER
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DXH
2004-06-28
REMOTENURSE PATIENT MONITORING SYSTEM
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DXH
2004-03-05
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002
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DXH
2004-02-05
HEARTRAK SMART AT/HEARTRAK SMART2
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DXH
2003-10-03
HEART 2006
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DXH
2003-07-09
TELZUIT CARDIAC MONITORING SYSTEM
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DXH
2003-06-23
PER, MODEL MEMO
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DXH
2003-02-11
MEDSTAR SYSTEM, MODELS 533-300
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DXH
2003-01-17
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM
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DXH
2003-01-15
TM2005 PERSONAL MEDICAL PHONE CENTER
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DXH
2002-11-06
HEARTONE EVENT RECORDER AND TRANSMITTER
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DXH
2002-07-24
HEARTLINE RECEIVING STATION
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DXH
2002-04-05
NETLINK/NETSCAN
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DXH
2002-02-01
TM2000, MODEL 1
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DXH
2002-01-17
ECG HOME
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DXH
2001-10-30
TM2000 EASYTRACE PLUS RECEIVING CENTER
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DXH
2001-09-10
CG-2211 SELFCHECK ECG TRANSMITTER
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DXH
2001-08-14
PACEART TX3 CARDIAC EVENT RECORDER
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DXH
2001-08-14
CG-3250 MINIRECEIVER
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DXH
2001-07-20
CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM
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DXH
2001-06-12
HEARTCARD, MODEL 5258
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DXH
2001-06-08
REMOTE PRESENCE AND CARE SYSTEM (RPCS 5000)
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DXH
2001-05-14
TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011
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DXH
2001-05-10
BRIDGE III RECEIVER
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DXH
2000-12-21
CARDIOSENTRY EVENT MONITOR, MODEL 8470-01
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DXH
2000-11-08
PERSONAL ECG TRANSMITTER, MODEL CG-6550
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DXH
2000-10-25
CARDIOBEEPER CB12/12, MODEL CB12/12
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DXH
2000-09-21
ZYBIT
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DXH
2000-08-10
CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01
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DXH
2000-05-17
HEART 2005
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DXH
2000-02-11
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306
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DXH
1999-12-21
CG-2100 ECG TRANSMITTER
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DXH
1999-12-10
CG-7000DX ECG RECORDER/TRANSMITTER
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DXH
1999-10-07
ECG MINIMONITOR, MODEL CG-5000
View details →No matching devices.
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