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
97–120 of 339
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 Sep 29, 1983
PATIENT MONITOR #78353A
K831787
Hewlett-Packard Co.
Cardiovascular · 118d
Cleared Aug 12, 1983
PHYSIOLOGICAL MONITOR #902
K831578
Novametrix Medical Systems, Inc.
Cardiovascular · 87d
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 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 Jul 02, 1982
TELCOR 2
K821755
Burdick Corp.
Cardiovascular · 17d
Cleared Jun 25, 1982
PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000
K821720
Novametrix Medical Systems, Inc.
Cardiovascular · 15d
Cleared May 25, 1982
MODELS 78504A & 78508A PATIENT MON. SYS
K821368
Hewlett-Packard Co.
Cardiovascular · 15d
Cleared Apr 15, 1982
CARDIAC MONITOR - RATE ALARM
K820825
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Apr 01, 1982
DIASCOPE 2
K820745
Puritan Bennett Corp.
Cardiovascular · 13d
Cleared Mar 04, 1982
#505 PORT. VITAL FUNCTIONS NEONATAL MON
K820416
Ge Medical Systems Information Technologies
Cardiovascular · 16d
Cleared Mar 04, 1982
#506 PORT. VITAL FUNCTIONS NEONATAL MON
K820417
Ge Medical Systems Information Technologies
Cardiovascular · 16d
Cleared Dec 29, 1981
NIHON KOHDEN HEART MONITORS OMP 7101-02
K813444
Nihon Kohden America, Inc.
Cardiovascular · 20d
Cleared Nov 16, 1981
MODEL 2000 MONITOR
K812828
Datascope Corp.
Cardiovascular · 39d
Cleared Sep 08, 1981
NOVAMETRIX PHYSIOLOGICAL MONITOR #910
K811893
Novametrix Medical Systems, Inc.
Cardiovascular · 69d
Cleared Aug 31, 1981
CENTRAL STATION MONITOR
K812271
Datascope Corp.
Cardiovascular · 18d
Cleared Jul 02, 1981
RESIDENT BEDSIDE MONITOR
K811216
Abbott Laboratories
Cardiovascular · 59d