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..

339
Total
339
Cleared
123d
Avg days
1976
Since
339 devices
121–144 of 339
Cleared Sep 20, 1984
SERVOMED OXCARDIORE SPIROGRAPH 324/111
K840832
Litton Medical Electronics
Cardiovascular · 209d
Cleared Sep 11, 1984
FUKUDA DENSHI FX-302 AUTO/THREE CHAN
K833594
Brentwood Instruments, Inc.
Cardiovascular · 335d
Cleared Sep 11, 1984
HOLTER SCREENING MONITOR HS-221
K842462
Advantage Medical Systems, Inc.
Cardiovascular · 81d
Cleared Aug 28, 1984
LIFESCOPE II
K841499
Nihon Kohden America, Inc.
Cardiovascular · 140d
Cleared Aug 28, 1984
LIFESCOPE 6 OEC-6102
K841501
Nihon Kohden America, Inc.
Cardiovascular · 140d
Cleared Aug 28, 1984
LIFESCOPE 6 OEC-6105
K841502
Nihon Kohden America, Inc.
Cardiovascular · 140d
Cleared Aug 22, 1984
DYNASCOPE SERIES
K840055
Fukuda Denshi USA, Inc.
Cardiovascular · 229d
Cleared Aug 03, 1984
AIR SHIELDS AS461 MONITORING SYS
K842321
Air-Shields, Inc.
Cardiovascular · 52d
Cleared Jun 01, 1984
SERVOMED BASIC BEDSIDE UNIT SMA 102-
K832250
Litton Medical Electronics
Cardiovascular · 326d
Cleared Jun 01, 1984
EXTENSION BOX EB200
K834530
Honeywell, Inc.
Cardiovascular · 163d
Cleared Jun 01, 1984
RECOMB ECG PREAMPLIFIER/206 069 03
K834600
Litton Medical Electronics
Cardiovascular · 154d
Cleared Jun 01, 1984
SERVOMED DIGITAL DISPLAY MODULE
K840521
Litton Medical Electronics
Cardiovascular · 115d
Cleared Jun 01, 1984
SERVOMED COMPACT MONITOR SMK 155-1/101
K840525
Litton Medical Electronics
Cardiovascular · 115d
Cleared Apr 17, 1984
NEONATAL PHYSIOLOGICAL MONITOR 903
K840560
Novametrix Medical Systems, Inc.
Cardiovascular · 69d
Cleared Mar 22, 1984
SERVOMED COMPACT MONITOR SMK 155-7/101
K832025
Litton Medical Electronics
Cardiovascular · 273d
Cleared Mar 22, 1984
SEVOMED COMPACT MONITOR SMK 154-
K832095
Litton Medical Electronics
Cardiovascular · 268d
Cleared Feb 27, 1984
PATIENT MONITOR 78534B
K840251
Hewlett-Packard Co.
Cardiovascular · 54d
Cleared Jan 27, 1984
TREND PROCESSOR OPTION FOR #515 NEONAT
K833552
Ge Medical Systems Information Technologies
Cardiovascular · 105d
Cleared Dec 01, 1983
PATIENT MONITOR CM 135
K831164
Honeywell, Inc.
Cardiovascular · 234d
Cleared Nov 16, 1983
SERVOMED COMPACT MONITOR SMK 154-8/101
K832021
Litton Medical Electronics
Cardiovascular · 146d
Cleared Nov 16, 1983
SERVOMED COMPACT MONITOR SMK 155-9
K832035
Litton Medical Electronics
Cardiovascular · 146d
Cleared Nov 16, 1983
SERVOMED CENTRAL STATION SMV 206
K832131
Litton Medical Electronics
Cardiovascular · 138d
Cleared Oct 31, 1983
PATIENT MONITOR #RM-100
K831817
Honeywell, Inc.
Cardiovascular · 147d
Cleared Oct 31, 1983
CENTRAL STATION MONITOR CSM-100
K831818
Honeywell, Inc.
Cardiovascular · 147d