DRT · Class II · 21 CFR 870.2300

FDA Product Code DRT: Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

Leading manufacturers include Hewlett-Packard Co., Litton Medical Electronics and Nihon Kohden America, Inc..

339
Total
339
Cleared
123d
Avg days
1976
Since
339 devices
25–48 of 339
Cleared Oct 19, 1995
EAGLE 3000 PATIENT MONITOR
K952474
Marquette Electronics, Inc.
Cardiovascular · 142d
Cleared May 12, 1995
ECG MONITOR
K944262
Fukuda Denshi USA, Inc.
Cardiovascular · 255d
Cleared Sep 21, 1994
LIONHEART 3 MULTI-PARAMETER SIMULATOR
K944257
Bio-Tek Instruments, Inc.
Cardiovascular · 21d
Cleared Feb 05, 1993
SYSTEM ATHENA, MODIFICATION
K911611
S & W Medico Teknik
Cardiovascular · 668d
Cleared Nov 09, 1992
HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING
K921194
Hewlett-Packard Co.
Cardiovascular · 242d
Cleared Dec 31, 1991
MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED
K910665
Ge Medical Systems Information Technologies
Cardiovascular · 323d
Cleared Dec 05, 1991
SYSTEM ATHENA - PRODUCT ENHANCEMENTS
K912049
S & W Medico Teknik
Cardiovascular · 240d
Cleared Oct 15, 1991
DATASCOPE PASSPORT MONITOR
K911598
Datascope Corp.
Cardiovascular · 189d
Cleared Jun 11, 1991
HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A
K911139
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Feb 07, 1991
WEP-8430A TELEMETRY CENTRAL STATION
K904696
Nihon Kohden America, Inc.
Cardiovascular · 176d
Cleared Aug 23, 1990
MORTARA INSTRUMENT MODEL ELI 50
K902652
Mortara Instrument, Inc.
Cardiovascular · 69d
Cleared Apr 20, 1990
TYPE 9040/NEO
K896699
S & W Medico Teknik
Cardiovascular · 143d
Cleared Apr 20, 1990
TYPE 9140/NEO
K896700
S & W Medico Teknik
Cardiovascular · 143d
Cleared Apr 19, 1990
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
K901034
Nihon Kohden America, Inc.
Cardiovascular · 44d
Cleared Apr 10, 1990
MODEL M1175A/M1176A WITH ST SEGMENT MONITORING
K900032
Hewlett-Packard Co.
Cardiovascular · 98d
Cleared Apr 04, 1990
MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM
K895801
Marquette Electronics, Inc.
Cardiovascular · 188d
Cleared Mar 06, 1990
CARDIOCAP(TM) CT-104 MONITOR
K897080
Datex Division Instrumentarium Corp.
Cardiovascular · 75d
Cleared Oct 03, 1989
ERGOMED 840/ERGOMED 840L
K885085
Burdick Corp.
Cardiovascular · 298d
Cleared Oct 02, 1989
MODEL DS-504 DYNASCOPE PATIENT MONITOR
K893405
Fukuda Denshi USA, Inc.
Cardiovascular · 153d
Cleared Oct 02, 1989
TYPE 9140 (SYSTEM ATHENA)
K894699
S & W Medico Teknik
Cardiovascular · 70d
Cleared Oct 02, 1989
TYPE PDU/CDU 9040 (SYSTEM ATHENA)
K894700
S & W Medico Teknik
Cardiovascular · 70d
Cleared May 23, 1989
HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S
K892006
Healthdyne, Inc.
Cardiovascular · 56d
Cleared Apr 26, 1989
TYPE 9210 ECG SYSTEM ATHENA
K884117
S & W Medico Teknik
Cardiovascular · 208d
Cleared Jan 17, 1989
MINIMON 7134B PATIENT MONITOR
K883069
Kontron Instruments, Inc.
Cardiovascular · 181d