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
73–96 of 297
Cleared Sep 17, 1999
CARDIOPHONICS 1000 MEMORY MONITOR
K992772
Rlt Medical Assoc., Inc.
Cardiovascular · 30d
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 Jul 08, 1999
EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM
K991211
Reynolds Medical , Ltd.
Cardiovascular · 90d
Cleared Jun 14, 1999
TELEMEDICINE 2000
K991307
Card Guard Scientific Survival , Ltd.
Cardiovascular · 59d
Cleared Feb 19, 1999
E-FAX SYSTEM
K982034
Blakbag, Ltd., Division of Coherent Systems
Cardiovascular · 254d
Cleared Feb 05, 1999
KING OF HEARTS EXPRESS II & KING OF HEARTS EXPRESS EZ II
K983626
Alaris Medical Systems, Inc.
Cardiovascular · 113d
Cleared Jan 26, 1999
PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM
K982090
Paceart, Inc.
Cardiovascular · 225d
Cleared Jan 14, 1999
FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25
K982228
Tz Medical, Inc.
Cardiovascular · 203d
Cleared Dec 02, 1998
PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000
K983026
Card Guard Scientific Survival , Ltd.
Cardiovascular · 93d
Cleared Nov 13, 1998
CARDIOBEEPER CB250
K983582
Merdian Medical Technologies , Ltd.
Cardiovascular · 31d
Cleared Oct 14, 1998
CARDIOPAL MODEL NUMBER PM20
K981119
Medicomp, Inc.
Cardiovascular · 201d
Cleared Sep 28, 1998
BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720
K981394
Braemar Corp.
General Hospital · 164d
Cleared Jun 16, 1998
HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER
K980144
Aerotel, Ltd.
Cardiovascular · 152d
Cleared May 11, 1998
CARDIOSTATION
K980624
Universal Medical, Inc.
Cardiovascular · 82d
Cleared Jan 29, 1998
TTM5000 TELEPHONIC EKG MONITOR
K973267
Hds Medical, Inc.
Cardiovascular · 153d
Cleared Jan 02, 1998
MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR
K973863
Hi-Tronics Designs, Inc.
Cardiovascular · 85d
Cleared Dec 30, 1997
SENTINEL RECORDER, MODELS 471/472
K971696
Del Mar Avionics
Cardiovascular · 236d
Cleared Dec 04, 1997
RHYTHMSTAT XL
K971650
Data Critical Corp.
Cardiovascular · 212d
Cleared Dec 04, 1997
CARDIOCALL CARDIAC EVENT RECORDER
K972649
Reynolds Medical , Ltd.
Cardiovascular · 142d
Cleared Nov 12, 1997
HEART ACCESS PLUS CARDIAC EVENT RECORDER
K973141
Paceart, Inc.
Cardiovascular · 83d
Cleared Sep 10, 1997
MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)
K963725
Card Guard , Ltd.
Cardiovascular · 415d
Cleared Aug 15, 1997
PRINTER INTERFACE
K970305
Micromedical, Inc.
Cardiovascular · 200d
Cleared Jul 28, 1997
CARD GUARD, MODEL CG-7100
K964836
Card Guard Scientific Survival , Ltd.
Cardiovascular · 241d