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
121–144 of 297
Cleared Mar 30, 1994
CARD GUARD MODEL CG-8000
K926515
Card Guard Scientific Survival , Ltd.
Cardiovascular · 455d
Cleared Jun 22, 1993
CARDIOMAGIC SOFTWARE
K925639
Instromedix, Inc.
Cardiovascular · 225d
Cleared Oct 14, 1992
KING OF HEARTS EXPRESS (E.X.) MONITOR
K920984
Instromedix, Inc.
Cardiovascular · 226d
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 Jun 17, 1991
PDT CARRYALL TRANSMITTER, VARIOUS MODELS
K912379
Cardiac Pacemakers, Inc.
Cardiovascular · 19d
Cleared Oct 09, 1990
MODEL 9444 TELETRACE II ECG MONITORING SYSTEM
K903960
Medtronic Vascular
Cardiovascular · 42d
Cleared Jul 27, 1990
ESCORT MODEL 400T TELEMETRY ECG MONITOR
K902254
Medical Data Electronics
Cardiovascular · 67d
Cleared May 15, 1990
KING OF HEARTS CDM
K896040
Instromedix, Inc.
Cardiovascular · 211d
Cleared May 15, 1990
ESCORT-LINK (MODEL E3200)
K901591
Medical Data Electronics
Cardiovascular · 40d
Cleared Feb 28, 1990
KING OF HEARTS 1200 MONITOR
K896039
Instromedix, Inc.
Cardiovascular · 135d
Cleared Jan 19, 1990
CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTER
K896002
Instromedix, Inc.
Cardiovascular · 98d
Cleared Oct 12, 1989
TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000
K894540
Physio-Control Corp.
Cardiovascular · 84d
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 Dec 16, 1988
OXINET N-7500 PULSE OXIMETRY NETWORK
K884142
Nellcor, Inc.
Cardiovascular · 77d
Cleared Jul 22, 1988
CARD GUARD, MODEL CG-2000
K882290
Card Guard Scientific Survival , Ltd.
Cardiovascular · 51d
Cleared Jul 12, 1988
ESCORT - PORTABLE PATIENT MONITOR
K881986
Medical Data Electronics
Cardiovascular · 61d
Cleared Apr 11, 1988
KING OF HEARTS
K880626
Instromedix, Inc.
Cardiovascular · 55d
Cleared Nov 04, 1987
STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE)
K872869
Labeltape Meditect, Inc.
Cardiovascular · 106d
Cleared May 14, 1987
MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR
K870652
Medtronic Vascular
Cardiovascular · 86d
Cleared Feb 28, 1986
WEP 7604 TELEMETRY MONITOR
K854369
Nihon Kohden America, Inc.
Cardiovascular · 122d