DXH · Class II · 21 CFR 870.2920

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

Leading manufacturers include Medtronic Vascular, AliveCor, Inc. and Intermedics, 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 Jan 30, 1992
MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR
K915769
Medtronic Vascular
Cardiovascular · 37d
Cleared Nov 07, 1991
MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS)
K913533
Hewlett-Packard Co.
Cardiovascular · 90d
Cleared Jul 30, 1991
MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221
K912084
Medtronic Vascular
Cardiovascular · 78d
Cleared Oct 09, 1990
MODEL 9444 TELETRACE II ECG MONITORING SYSTEM
K903960
Medtronic Vascular
Cardiovascular · 42d
Cleared Sep 26, 1989
MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING
K893471
Medtronic Vascular
Cardiovascular · 145d
Cleared Sep 26, 1989
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
K894277
Hewlett-Packard Co.
Cardiovascular · 95d
Cleared Jul 27, 1989
MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER
K894140
Medtronic Vascular
Cardiovascular · 44d
Cleared May 14, 1987
MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR
K870652
Medtronic Vascular
Cardiovascular · 86d
Cleared Oct 22, 1985
#9431 TELETRACE, TELEPHONE, EKG TRANSMITTER
K852971
Medtronic Vascular
Cardiovascular · 99d
Cleared Dec 07, 1984
PAGE-WRITER INTERPRETIVE CARDIOGRAPH
K842370
Hewlett-Packard Co.
Cardiovascular · 175d
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 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