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
265–288 of 341
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 Jan 22, 1982
BRADYCARDIA ALARM
K813174
Douglas Scientific Products
Cardiovascular · 77d
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 21, 1981
PORTAPULSE
K812131
Gavon, Inc.
Cardiovascular · 55d
Cleared Sep 16, 1981
CARDIACMONITORS
K811425
Pulse Time Products, Ltd.
Cardiovascular · 117d
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 Apr 03, 1981
SQUINN VITATEK 500 SERIES PHYSIOL. MONI
K810755
Vitatek
Cardiovascular · 14d
Cleared Jan 13, 1981
ADVANCMED ELIMINATOR
K803223
American Edwards Laboratories
Cardiovascular · 25d
Cleared Nov 19, 1980
THE CRITERION II PACING SYS. MONITOR
K802782
Dart Medical Equipment
Cardiovascular · 16d
Cleared Oct 31, 1980
WISCONSIN HEART RATE MONITOR
K802182
Lunar Radiation Corp.
Cardiovascular · 52d
Cleared Oct 23, 1980
CRITERION II PACING SYSTEM MONITORS
K802325
Dart Medical Equipment
Cardiovascular · 30d
Cleared Oct 03, 1980
CT-1600 DIGITAL PULSE RATE MONITOR
K802204
Industrial & Biomedical Sensors Corp.
Cardiovascular · 22d
Cleared Sep 26, 1980
HEARTWATCH
K800519
D. Jenkins
Cardiovascular · 204d
Cleared Sep 26, 1980
HS10 PORTABLE OPERATING ROOM MONITOR
K802184
Medtel Pty. , Ltd.
Cardiovascular · 16d