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
49–72 of 297
Cleared Apr 20, 2010
VITAPHONE. MODEL 100 BT
K100383
Vitasystems GmbH
Cardiovascular · 63d
Cleared Mar 25, 2010
RAISIN PERSONAL MONITOR
K093976
Proteus Biomedical, Inc.
Cardiovascular · 91d
Cleared Dec 17, 2009
HEALTHEPOD
K083174
Card Guard Scientific Survival , Ltd.
Cardiovascular · 416d
Cleared Apr 23, 2009
CLUE MEDICAL AND CLUE MEDICAL BASIC
K083630
Telovital GmbH Telemedizin
Cardiovascular · 136d
Cleared Dec 15, 2008
HEARTRAK SMART ECAT
K083535
Universal Medical, Inc.
Cardiovascular · 17d
Cleared Oct 10, 2008
TEMPUSIC PATIENT MONITOR
K082718
Remote Diagnostic Technologies , Ltd.
Cardiovascular · 23d
Cleared Sep 02, 2008
BT3/6, BT12
K082077
Corscience GmbH & Co. KG
Cardiovascular · 41d
Cleared Jul 11, 2008
CARDIOSEN'C
K080047
Shl Telemedicine International , Ltd.
Cardiovascular · 185d
Cleared Jun 24, 2008
ECARD AND CCARD
K081471
iRhythm Technologies, Inc.
Cardiovascular · 28d
Cleared May 14, 2008
HEARTRAK AF
K071130
Universal Medical, Inc.
Cardiovascular · 387d
Cleared Jan 11, 2008
HEARTEVENT, MODEL AT
K072385
Diagnostic Devices Pty, Ltd.
Cardiovascular · 140d
Cleared Nov 21, 2007
FIDELITY 200 CARDIAC EVENT RECORDER
K071228
Signalife, Inc.
Cardiovascular · 202d
Cleared Sep 12, 2007
RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER
K063609
Shl Telemedicine International , Ltd.
Cardiovascular · 282d
Cleared Jan 25, 2007
SENTINEL
K062397
Del Mar Reynolds Medical, Ltd.
Cardiovascular · 162d
Cleared Sep 15, 2006
TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +
K061780
Rozinn Electronics, Inc.
Cardiovascular · 81d
Cleared Aug 22, 2006
CG-6108 ARRHYTHMIA ECG EVENT RECORDER
K060911
Card Guard Scientific Survival , Ltd.
Cardiovascular · 141d
Cleared Aug 02, 2006
PEPER
K060297
Medical Monitors, Ltd.
Cardiovascular · 177d
Cleared Jul 21, 2006
PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES
K061977
Pinmed, Inc.
Cardiovascular · 8d
Cleared Jun 23, 2006
AFIBALERT ATRIAL FIBRILLATION DETECTOR
K052767
Lechnologies Research, Inc.
Cardiovascular · 266d
Cleared Feb 23, 2006
LOOP RECORDER VITAPHONE, 3100 SERIES
K053378
Tms Telemedizinische Systeme GmbH
Cardiovascular · 80d
Cleared Jan 09, 2006
CG-7000DX-BT ECG RECORDER/TRANSMITTER
K052556
Card Guard Scientific Survival , Ltd.
Cardiovascular · 115d
Cleared Oct 07, 2005
VITALCAREGIVING SYSTEM
K051544
Advanced Monitoring Caregiving, Inc.
Cardiovascular · 119d
Cleared Aug 19, 2005
CARDIONAVIGATOR +
K051960
Del Mar Reynolds Medical, Ltd.
Cardiovascular · 31d
Cleared Jul 19, 2005
MEDSTAR 220, MODEL 533-220
K050951
Cibernet Systems Corp.
Cardiovascular · 95d