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
145–168 of 297
Cleared Jan 22, 1986
CMS 8000
K853096
Physio-Control Corp.
Cardiovascular · 183d
Cleared Oct 22, 1985
#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER
K852971
Medtronic Vascular
Cardiovascular · 99d
Cleared May 15, 1985
R-1000 ECG RECEIVER
K851123
Brentwood Instruments, Inc.
Cardiovascular · 57d
Cleared May 15, 1985
T-1000 ECG TRANSMITTER
K851124
Brentwood Instruments, Inc.
Cardiovascular · 57d
Cleared Feb 08, 1985
MDE ESCORT 1000 & MDE ESCOR 2000
K842716
Medical Data Electronics
Cardiovascular · 210d
Cleared Dec 07, 1984
PAGE-WRITER INTERPRETIVE CARDIOGRAPH
K842370
Hewlett-Packard Co.
Cardiovascular · 175d
Cleared Oct 26, 1984
INSTANT REPLAY
K840587
Instromedix, Inc.
Cardiovascular · 261d
Cleared May 09, 1984
MODEM ACCESSORY FOR EPI CARDIA SYS
K834034
Medicomp, Inc.
Cardiovascular · 168d
Cleared Aug 12, 1983
PACELINE PATIENT TRANSMITTER MODEL 324
K831443
Pacesetter Systems
Cardiovascular · 99d
Cleared May 09, 1983
CARDIOMEMO III
K830477
Instromedix, Inc.
Cardiovascular · 83d
Cleared Jan 21, 1983
SIRECUST 456
K830028
Analogic Corp.
Cardiovascular · 17d
Cleared Nov 01, 1982
MODEL 4242 TELE SYST ARRHYTHMIA MONITOR
K822955
Medtronic Vascular
Cardiovascular · 27d
Cleared Jul 08, 1982
MODEL 535-02 TRACE-A-PACE TRANSMITTER
K821726
Intermedics, Inc.
Cardiovascular · 27d
Cleared Nov 16, 1981
MODEL 535-03 TRACE A PACE
K812755
Intermedics, Inc.
Cardiovascular · 47d
Cleared Oct 23, 1981
MODEL 9408 A TELETRACE
K812703
Medtronic Vascular
Cardiovascular · 31d
Cleared Sep 23, 1981
MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY
K811464
Intermedics, Inc.
Cardiovascular · 120d
Cleared Jun 30, 1981
TELETRACE TELEPHONE EKG SYSTEM
K811512
Medtronic Vascular
Cardiovascular · 33d
Cleared Jan 22, 1981
HP MODEL 4710A ECG TRANSMITTER
K802717
Hewlett-Packard Co.
Cardiovascular · 83d
Cleared Sep 26, 1980
CARDIOTRAK
K802089
Cardiac Pacemakers, Inc.
Cardiovascular · 24d
Cleared Aug 07, 1980
UNI-RECORD I
K801700
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 14d
Cleared Dec 05, 1979
MEDTRONIC MODEL 9407 TELETRACE TRANSMITT
K792359
Medtronic Vascular
Cardiovascular · 14d
Cleared Nov 21, 1979
MEDTRONIC MODEL 9408 TELETRACE TRANSMIT
K792246
Medtronic Vascular
Cardiovascular · 14d
Cleared Oct 02, 1979
MEDTRONIC MODEL 9410 TELETRACE RECEIVER
K791778
Medtronic Vascular
Cardiovascular · 22d
Cleared Dec 21, 1978
TRANSMITTER, TR-1 ECG
K782059
Burdick Corp.
Cardiovascular · 14d