DXH · Class II · 21 CFR 870.2920

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

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

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 17, 2009
HEALTHEPOD
K083174
Card Guard Scientific Survival , Ltd.
Cardiovascular · 416d
Cleared Aug 22, 2006
CG-6108 ARRHYTHMIA ECG EVENT RECORDER
K060911
Card Guard Scientific Survival , Ltd.
Cardiovascular · 141d
Cleared Jan 09, 2006
CG-7000DX-BT ECG RECORDER/TRANSMITTER
K052556
Card Guard Scientific Survival , Ltd.
Cardiovascular · 115d
Cleared Jul 01, 2005
PMP4 MEDICAL WEB CENTER
K050940
Card Guard Scientific Survival , Ltd.
Cardiovascular · 78d
Cleared Jan 13, 2005
PMP4 SELFCHECK ECG
K042254
Card Guard Scientific Survival , Ltd.
Cardiovascular · 146d
Cleared Jan 17, 2003
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM
K023689
Card Guard Scientific Survival , Ltd.
Cardiovascular · 77d
Cleared Jan 15, 2003
TM2005 PERSONAL MEDICAL PHONE CENTER
K024365
Card Guard Scientific Survival , Ltd.
Cardiovascular · 15d
Cleared Feb 01, 2002
TM2000, MODEL 1
K013879
Card Guard Scientific Survival , Ltd.
Cardiovascular · 70d
Cleared Oct 30, 2001
TM2000 EASYTRACE PLUS RECEIVING CENTER
K013175
Card Guard Scientific Survival , Ltd.
Cardiovascular · 36d
Cleared Sep 10, 2001
CG-2211 SELFCHECK ECG TRANSMITTER
K012223
Card Guard Scientific Survival , Ltd.
Cardiovascular · 56d
Cleared Aug 14, 2001
CG-3250 MINIRECEIVER
K012187
Card Guard Scientific Survival , Ltd.
Cardiovascular · 33d
Cleared Nov 08, 2000
PERSONAL ECG TRANSMITTER, MODEL CG-6550
K003220
Card Guard Scientific Survival , Ltd.
Cardiovascular · 23d
Cleared Feb 11, 2000
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306
K000225
Card Guard Scientific Survival , Ltd.
Cardiovascular · 18d
Cleared Dec 21, 1999
CG-2100 ECG TRANSMITTER
K994009
Card Guard Scientific Survival , Ltd.
Cardiovascular · 25d
Cleared Dec 10, 1999
CG-7000DX ECG RECORDER/TRANSMITTER
K993799
Card Guard Scientific Survival , Ltd.
Cardiovascular · 31d
Cleared Oct 07, 1999
ECG MINIMONITOR, MODEL CG-5000
K992696
Card Guard Scientific Survival , Ltd.
Cardiovascular · 56d
Cleared Aug 31, 1999
CARD GUARD, MODEL CG-6550
K990478
Card Guard Scientific Survival , Ltd.
Cardiovascular · 196d
Cleared Aug 30, 1999
TELEMEDICINE 2000
K992164
Card Guard Scientific Survival , Ltd.
Cardiovascular · 66d
Cleared Jun 14, 1999
TELEMEDICINE 2000
K991307
Card Guard Scientific Survival , Ltd.
Cardiovascular · 59d
Cleared Dec 02, 1998
PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000
K983026
Card Guard Scientific Survival , Ltd.
Cardiovascular · 93d