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 Ivy Biomedical Systems, Inc..

341
Total
341
Cleared
123d
Avg days
1976
Since
341 devices
169–192 of 341
Cleared May 21, 1985
MICROCOR ECG MONITOR
K851325
Microcor, Inc.
Cardiovascular · 47d
Cleared May 16, 1985
KONTRON SUPERMON 7210 PATIENT MONITOR
K844731
Kontron Instruments, Inc.
Cardiovascular · 163d
Cleared May 16, 1985
MEDWATCH 400 CARDIAC CENTRAL NURSES STATION
K850135
Medwatch Systems, Inc.
Cardiovascular · 122d
Cleared Apr 25, 1985
HORIZON 1000 CARDIAC MONITOR
K850880
Mennen Medical, Inc.
Cardiovascular · 52d
Cleared Apr 18, 1985
NEONATAL MONITOR 309
K850407
Rigel Medical Electronics, Inc.
Cardiovascular · 73d
Cleared Apr 11, 1985
SIEMENS SIRECUST 404N NEONATAL MONITOR
K844187
Siemens Medical Solutions USA, Inc.
Cardiovascular · 164d
Cleared Apr 04, 1985
KONTRON MINIMON 7134 PATIENT MONITOR
K844215
Kontron Instruments, Inc.
Cardiovascular · 155d
Cleared Mar 27, 1985
KONTRON MINIMON 7132 PATIENT MONITOR
K844732
Kontron Instruments, Inc.
Cardiovascular · 113d
Cleared Mar 27, 1985
KONTRON MINIMON 7131 PATIENT MONITOR
K844733
Kontron Instruments, Inc.
Cardiovascular · 113d
Cleared Mar 01, 1985
LS 5
K842037
Life Science Instrumentation, Inc.
Cardiovascular · 294d
Cleared Mar 01, 1985
ECG PATIENT MONITOR 302
K850155
Rigel Medical Electronics, Inc.
Cardiovascular · 45d
Cleared Mar 01, 1985
ECG PATIENT MONITOR 301
K850156
Rigel Medical Electronics, Inc.
Cardiovascular · 45d
Cleared Feb 22, 1985
C/PES 9201, ECG STRESS TESTING SYS
K850114
Gould, Inc.
Cardiovascular · 39d
Cleared Feb 08, 1985
CARDIOGUARD STRESS TEST MONITOR 4002
K850043
Del Mar Avionics
Cardiovascular · 32d
Cleared Feb 08, 1985
C/PES 9103, ECG STRESS TESTING SYSTEM
K850113
Gould, Inc.
Cardiovascular · 25d
Cleared Feb 01, 1985
SPACELABS SERIES 600 PATIENT MONITORS
K844888
Spacelabs, Inc.
Cardiovascular · 46d
Cleared Jan 18, 1985
PATIENT MONITOR 78354A
K842236
Hewlett-Packard Co.
Cardiovascular · 227d
Cleared Jan 18, 1985
ARRHYTHMIA CENTRAL-OGP-7201
K844911
Nihon Kohden America, Inc.
Cardiovascular · 31d
Cleared Dec 27, 1984
ECG PATIENT MONITOR
K843376
Rigel Medical Electronics, Inc.
Cardiovascular · 121d
Cleared Dec 11, 1984
CARE 5000 CENTRAL MONITOR MS5220 ETC.
K842582
Care Monitoring Systems
Cardiovascular · 161d
Cleared Dec 04, 1984
DYNASCOPE MONITOR DS-800
K844348
Fukuda Denshi USA, Inc.
Cardiovascular · 35d
Cleared Oct 29, 1984
SERVOMED PULSE AMPLIFIER MODULE-206-
K840523
Litton Medical Electronics
Cardiovascular · 265d
Cleared Oct 26, 1984
DIASCOPE 2
K833689
S & W Medico Teknik
Cardiovascular · 374d
Cleared Oct 26, 1984
SERVOMED BASIC BEDSIDE UNIT SMV 110TP
K840524
Litton Medical Electronics
Cardiovascular · 262d