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..

341
Total
341
Cleared
123d
Avg days
1976
Since
341 devices
193–216 of 341
Cleared Oct 02, 1984
HEART RATE/RESPIRATION SIMULATOR 8310
K841363
Aequitron Medical, Inc.
Cardiovascular · 183d
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 22, 1983
ACTIMETER UB-103
K832724
Copal, Inc.
Cardiovascular · 132d
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