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
49–72 of 339
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 05, 1986
LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC
K862463
Nihon Kohden America, Inc.
Cardiovascular · 158d
Cleared Mar 26, 1986
PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM
K855125
Honeywell, Inc.
Cardiovascular · 93d
Cleared Mar 11, 1986
PATIENT MONITOR PB240
K853318
Puritan Bennett Corp.
Cardiovascular · 216d
Cleared Mar 11, 1986
SIRECUST 341 AND 341R
K854881
Siemens Medical Solutions USA, Inc.
Cardiovascular · 95d
Cleared Aug 19, 1985
VSM MODELS A & B
K851916
Physio-Control Corp.
Cardiovascular · 109d
Cleared Jun 06, 1985
MODEL 78353B
K842817
Hewlett-Packard Co.
Cardiovascular · 323d
Cleared May 16, 1985
KONTRON SUPERMON 7210 PATIENT MONITOR
K844731
Kontron Instruments, Inc.
Cardiovascular · 163d
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 Feb 08, 1985
CARDIOGUARD STRESS TEST MONITOR 4002
K850043
Del Mar Avionics
Cardiovascular · 32d
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 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
Cleared Sep 20, 1984
SERVOMED OXCARDIORE SPIROGRAPH 324/111
K840832
Litton Medical Electronics
Cardiovascular · 209d
Cleared Aug 28, 1984
LIFESCOPE II
K841499
Nihon Kohden America, Inc.
Cardiovascular · 140d