DXH · Class II · 21 CFR 870.2920

FDA Product Code DXH: Transmitters And Receivers, Electrocardiograph, Telephone

Leading manufacturers include Card Guard Scientific Survival , Ltd., Instromedix, Inc. and Medtronic Vascular.

297
Total
297
Cleared
145d
Avg days
1976
Since
297 devices
25–48 of 297
Cleared Nov 30, 2018
Prizma
K173589
G-Medical Innovations , Ltd.
Cardiovascular · 375d
Cleared Sep 28, 2018
FibriCheck
K173872
Qompium NV
Cardiovascular · 282d
Cleared Aug 11, 2018
CARDIOSKIN
K173248
Bioserenity Sas
Cardiovascular · 305d
Cleared May 04, 2018
QT ECG
K180157
QT Medical, Inc.
Cardiovascular · 105d
Cleared Dec 15, 2017
BioFlux Device
K172311
Biotricity, Inc.
Cardiovascular · 136d
Cleared Nov 16, 2017
Kardia Band System
K171816
AliveCor, Inc.
Cardiovascular · 150d
Cleared Oct 18, 2017
ECG SENTINEL System
K172801
Cardiomedix, Inc.
Cardiovascular · 30d
Cleared Oct 02, 2017
ECG Check - Universal, ECG Check - Universal Plus
K170506
Cardiac Designs, Inc.
Cardiovascular · 223d
Cleared Sep 01, 2017
Prizma
K170181
G-Medical Innovations , Ltd.
Cardiovascular · 225d
Cleared Nov 30, 2016
SimplECG
K161431
Nanowear, Inc.
Cardiovascular · 190d
Cleared Apr 30, 2015
Vitaphone Tele ECG Loop Recorder
K151013
Vitasystems GmbH
Cardiovascular · 15d
Cleared Mar 29, 2015
eMotion Faros ECG Mobile
K143032
Mega Electronics , Ltd.
Cardiovascular · 158d
Cleared Feb 17, 2015
Master Caution Device MCD
K142476
Healthwatch , Ltd.
Cardiovascular · 167d
Cleared Jan 27, 2015
AliveCor Heart Monitor
K142743
AliveCor, Inc.
Cardiovascular · 125d
Cleared Dec 03, 2014
AliveCor Heart Monitor
K142672
AliveCor, Inc.
Cardiovascular · 75d
Cleared Aug 18, 2014
PHYSIOGLOVE ET SYSTEM
K133703
Commwell R&D , Ltd.
Cardiovascular · 258d
Cleared Aug 15, 2014
ALIVECOR HEART MONITOR
K140933
AliveCor, Inc.
Cardiovascular · 126d
Cleared Aug 05, 2014
RHYTHMSTAR SYSTEM
K141813
RhythMedix, LLC
Cardiovascular · 29d
Cleared Apr 04, 2014
CLOUDEKG
K130878
Makromed, Inc.
Cardiovascular · 371d
Cleared Mar 19, 2014
MELYS ATRIAL FIBRILLATION SCREENING MONITOR
K132206
Advanced Fluidics, LLC
Cardiovascular · 246d
Cleared Nov 26, 2013
EMOTION ECG MOBILE
K131699
Mega Electronics , Ltd.
Cardiovascular · 168d
Cleared Jun 25, 2013
EPI MINI ECG PORTABLE HEALTH MONITORING SYSTEM (EPI MINI)
K121628
Epi Mobile Health Solutions (S) Pte, Ltd.
Cardiovascular · 386d
Cleared Feb 14, 2013
ECG CHECK
K122184
Cardiac Designs, LLC
Cardiovascular · 206d
Cleared Feb 22, 2012
SMARTHEART
K113514
Shl Telemedicine International , Ltd.
Cardiovascular · 86d