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
97–120 of 297
Cleared Jul 18, 1997
CARDIOMAGIC 2000 SOFTWARE
K964036
Instromedix, Inc.
Cardiovascular · 283d
Cleared May 15, 1997
P.H.D. - PERSONAL HEART DEVICE MODEL 5258
K963904
Heart Alert, Inc.
Cardiovascular · 227d
Cleared Apr 10, 1997
CARDIO TEAM II
K962937
Vision Electronics
Cardiovascular · 255d
Cleared Mar 17, 1997
CARDIOBEEPER CB-12L
K965101
Meridian Medical Technologies, Inc.
Cardiovascular · 87d
Cleared Feb 28, 1997
CARDIACMONITOR
K963375
Vision Electronics
Cardiovascular · 185d
Cleared Feb 28, 1997
HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II
K964888
Tz Medical, Inc.
Cardiovascular · 84d
Cleared Dec 04, 1996
CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE
K963811
Card Guard Scientific Survival , Ltd.
Cardiovascular · 72d
Cleared Sep 10, 1996
CARD GUARD MODEL CG-6500
K954350
Card Guard Scientific Survival , Ltd.
Cardiovascular · 358d
Cleared Aug 06, 1996
HEARTRAK XL
K960499
Universal Medical, Inc.
Cardiovascular · 186d
Cleared Jul 18, 1996
HEART 400 ECG TRANSMITTER
K953762
Aerotel, Ltd.
Cardiovascular · 342d
Cleared Jul 11, 1996
RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER
K954163
Cardiac Evaluation Center, Inc.
Cardiovascular · 310d
Cleared Jul 10, 1996
AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE
K961362
Aerotel, Ltd.
Cardiovascular · 92d
Cleared Apr 22, 1996
PACETRAK PLUS
K954495
Universal Medical, Inc.
Cardiovascular · 208d
Cleared Apr 08, 1996
ACCELERATED TRANSMISSION PROTOCOL
K955060
Instromedix, Inc.
Cardiovascular · 158d
Cleared Jan 16, 1996
LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER
K951096
Instromedix, Inc.
Cardiovascular · 315d
Cleared Jan 16, 1996
PACEART CARDIOVOICE
K952065
Paceart, Inc.
Cardiovascular · 259d
Cleared Nov 09, 1995
HEARTHWATCH III(TM)
K945476
Instromedix, Inc.
Cardiovascular · 366d
Cleared Oct 31, 1995
CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS
K950003
Instromedix, Inc.
Cardiovascular · 301d
Cleared Sep 07, 1995
HEARTCARD CARDIAC EVENT MONITOR
K944362
Instromedix, Inc.
Cardiovascular · 365d
Cleared Apr 28, 1995
CG-1000 PERSONAL ECG TRANSMITTER
K935909
Card Guard Scientific Survival , Ltd.
Cardiovascular · 505d
Cleared Apr 04, 1995
CARRYALL ENHANCEMENTS
K943931
Instromedix, Inc.
Cardiovascular · 235d
Cleared Dec 05, 1994
CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER
K942704
Card Guard Scientific Survival , Ltd.
Cardiovascular · 180d
Cleared Nov 08, 1994
PRINCE
K935586
Instromedix, Inc.
Cardiovascular · 363d
Cleared Oct 31, 1994
CARD GUARD, MODEL CG-9000
K924486
Card Guard Scientific Survival , Ltd.
Cardiovascular · 788d