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
169–192 of 339
Cleared Jul 20, 1982
CARDIO-RESPIRATORY MONITOR MODEL CR-1
K821959
Electromed Intl., Ltd.
Cardiovascular · 20d
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 Jun 17, 1982
CR-9
K821223
Life Science Instrumentation, Inc.
Cardiovascular · 51d
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 Feb 12, 1982
SYSTEM V.HEART RATE/RESPIR. RATE MONIT.
K820114
Narco Air-Shields
Cardiovascular · 28d
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 Oct 13, 1981
INFANT CARIDAC MONITOR
K812674
Electromed Intl., Ltd.
Cardiovascular · 21d
Cleared Sep 25, 1981
CENTERAL MONITOR 360
K812144
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
CARDIORATER CR-3
K812145
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
CARDIORATER CR-5
K812146
Life Science Instrumentation, Inc.
Cardiovascular · 59d
Cleared Sep 25, 1981
CARDIORATER CR-7
K812147
Life Science Instrumentation, Inc.
Cardiovascular · 59d
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
Cleared Jan 13, 1981
ADVANCMED ELIMINATOR
K803223
American Edwards Laboratories
Cardiovascular · 25d
Cleared Aug 20, 1980
PDS COMPUTER UNIT/VIDEO TERMINAL
K801761
General Electric Co.
Cardiovascular · 23d
Cleared Jul 21, 1980
A-V MINI CLINIC
K800405
Instromedix, Inc.
Cardiovascular · 146d
Cleared Nov 21, 1979
HEART RATE MONITOR MD-1
K792312
Medical Devices, Inc.
Cardiovascular · 5d