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 Life Science Instrumentation, Inc..

339
Total
339
Cleared
123d
Avg days
1976
Since
339 devices
73–96 of 339
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 Jun 22, 1989
HORIZON CENTRAL STATION
K892066
Mennen Medical, Inc.
Cardiovascular · 84d
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 Mar 09, 1989
MODEL 702 ECG/RESPIRATION/TEMPERATURE
K884455
Ivy Biomedical Systems, Inc.
Cardiovascular · 136d
Cleared Feb 23, 1989
PATIENT MONITOR MODEL 701
K884096
Ivy Biomedical Systems, Inc.
Cardiovascular · 148d
Cleared Jan 17, 1989
MINIMON 7134B PATIENT MONITOR
K883069
Kontron Instruments, Inc.
Cardiovascular · 181d
Cleared May 13, 1988
RM-301 PATIENT MONITOR
K880498
Ppg Industries, Inc.
Cardiovascular · 98d
Cleared Mar 22, 1988
MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR
K880066
Ivy Biomedical Systems, Inc.
Cardiovascular · 71d
Cleared Jan 29, 1988
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
K874695
Healthdyne, Inc.
Cardiovascular · 74d
Cleared Jul 21, 1987
SERIES 2000 BEDSIDE PATIENT MONITOR
K872354
Marquette Electronics, Inc.
Cardiovascular · 33d
Cleared Jul 21, 1987
COMPANION 50 REGULATOR/FLOWMETER
K872443
Puritan Bennett Corp.
Cardiovascular · 28d
Cleared Dec 22, 1986
NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20
K863494
Advantage Medical Systems, Inc.
Cardiovascular · 104d
Cleared Dec 05, 1986
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463
Nihon Kohden America, Inc.
Cardiovascular · 158d
Cleared Nov 21, 1986
LIFE-WATCH MONITOR LT-8
K863534
Computerized Medical Systems, Inc.
Cardiovascular · 71d
Cleared Jun 16, 1986
ERG 550 ERGOMETER BICYCLE
K854491
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 16, 1986
ERG 551 ERGOMETER, BICYCLE
K854492
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 16, 1986
ERG 555 COUCH ERGOMETER
K854493
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 02, 1986
CARDIOCAP MONITOR
K853953
Instrumentarium Corp.
Cardiovascular · 250d