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
145–168 of 339
Cleared Oct 31, 1983
SERVOMED COMPACT MONITOR 181/10105002
K832018
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 26, 1983
LME HEART-RATE MONITOR
K832016
Litton Medical Electronics
Cardiovascular · 125d
Cleared Oct 26, 1983
SERVOMED BASIC BEDSIDE UNIT - VARIOUS
K832024
Litton Medical Electronics
Cardiovascular · 125d
Cleared Oct 26, 1983
SERVOMED BASIC BEDSIDE UNIT SMS 108 W/
K832026
Litton Medical Electronics
Cardiovascular · 125d
Cleared Oct 26, 1983
SERVOMED STANDARD SMS 104
K832041
Litton Medical Electronics
Cardiovascular · 124d
Cleared Oct 19, 1983
PATIENT MONITOR 788 33A
K831943
Hewlett-Packard Co.
Cardiovascular · 125d
Cleared Oct 19, 1983
PATIENT MONITOR #78832A
K831944
Hewlett-Packard Co.
Cardiovascular · 125d
Cleared Oct 14, 1983
AS 1740 INTERFACE MODULE
K831428
Narco Scientific
Cardiovascular · 164d
Cleared Sep 29, 1983
PATIENT MONITOR #78353A
K831787
Hewlett-Packard Co.
Cardiovascular · 118d
Cleared Sep 12, 1983
AIR SHIELDS AS-100 MONIORING SYS-AS105
K831430
Narco Scientific
Cardiovascular · 132d
Cleared Aug 12, 1983
PHYSIOLOGICAL MONITOR #902
K831578
Novametrix Medical Systems, Inc.
Cardiovascular · 87d
Cleared Jun 22, 1983
GOULD MODEL IM3000-IM3100 BATTERY POWER
K830885
Gould, Inc.
Cardiovascular · 93d
Cleared Jun 15, 1983
CENTRAL STATION DISPLAY/RECORDER MATRIX
K830517
Marquette Electronics, Inc.
Cardiovascular · 118d
Cleared Jun 08, 1983
VITAL SIGNS MONITOR 2
K830587
Physio-Control Corp.
Cardiovascular · 105d
Cleared May 25, 1983
MODEL 515 NEO-TRAK NEONATAL MONITOR
K823904
Ge Medical Systems Information Technologies
Cardiovascular · 148d
Cleared May 09, 1983
PRESSURE FUNCTION BLOCK FOR BLOOD PRESS
K830779
Honeywell, Inc.
Cardiovascular · 59d
Cleared Dec 30, 1982
NEUROMEDICS PACETRON HEART RATE MONITOR
K823290
Intermedics, Inc.
Cardiovascular · 55d
Cleared Nov 30, 1982
CADIO-RESPIRATORY MONITOR #CR-2
K823312
Electromed Intl., Ltd.
Cardiovascular · 25d
Cleared Oct 18, 1982
MODEL 78534A PATIENT MONITOR
K822876
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Oct 15, 1982
SIGNAL DISTRIBUTION NETWORK #78581A
K822695
Hewlett-Packard Co.
Cardiovascular · 38d
Cleared Sep 21, 1982
LIFE TRACE 40/42
K822389
Life Science Instrumentation, Inc.
Cardiovascular · 43d
Cleared Sep 21, 1982
LIFE TRACE 24
K822390
Life Science Instrumentation, Inc.
Cardiovascular · 43d
Cleared Sep 21, 1982
LIFE WATCH LSI
K822615
Life Science Instrumentation, Inc.
Cardiovascular · 22d
Cleared Aug 24, 1982
LIFE TRACE 14
K822388
Life Science Instrumentation, Inc.
Cardiovascular · 15d