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
121–144 of 339
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 Nov 21, 1979
HEART RATE MONITOR MD-1
K792312
Medical Devices, Inc.
Cardiovascular · 5d
Cleared Apr 03, 1979
MODEL 78801A PATIENT MONITORS
K790454
Hewlett-Packard Co.
Cardiovascular · 29d
Cleared Feb 26, 1979
MONITOR, ELECTROCARDIOSCOPE
K790292
Burdick Corp.
Cardiovascular · 17d
Cleared May 19, 1978
CSS-60 DIGITAL HEART RATE METER
K780702
Burdick Corp.
Cardiovascular · 24d
Cleared Mar 28, 1978
ECG MONITORING SYSTEM,
K780404
Quinton, Inc.
Cardiovascular · 15d
Cleared Feb 13, 1978
MONITOR, CARDIAC, BEDSIDE
K772332
Telectronics, Inc.
Cardiovascular · 53d
Cleared Nov 28, 1977
ACUTE CARDIAC CARE SYSTEM
K772006
Physio-Control Corp.
Cardiovascular · 38d
Cleared Nov 22, 1977
PHYSIOLOGICAL MONITOR MODEL 871
K772056
Datascope Corp.
Cardiovascular · 22d
Cleared Nov 22, 1977
HEARTRATE METER MODEL 650, P/N 000119
K772097
Quinton, Inc.
Cardiovascular · 15d
Cleared Nov 09, 1977
LINE CHARGER MODEL LC-100
K772053
Datascope Corp.
Cardiovascular · 9d
Cleared Aug 04, 1977
ECG SCOPE MODEL 7833
K771360
Hewlett-Packard Co.
Cardiovascular · 10d
Cleared Jul 25, 1977
SURGIPULSE HEART RATE MONITOR
K771199
Stryker Corp.
Cardiovascular · 20d
Cleared Feb 28, 1977
MONITOR, NEONATAL, MODEL 78261A
K770022
Hewlett-Packard Co.
Cardiovascular · 53d
Cleared Feb 28, 1977
MONITOR, NEONATE, MODEL 78213A
K770023
Hewlett-Packard Co.
Cardiovascular · 53d
Cleared Feb 28, 1977
MONITOR, NEONATAL, MODEL 78260A
K770024
Hewlett-Packard Co.
Cardiovascular · 53d
Cleared Feb 14, 1977
DIGITAL HEART RATE METER
K770239
Burdick Corp.
Cardiovascular · 7d
Cleared Jan 14, 1977
MONITOR, HEARTWATCH HEART RATE
K770038
Respironics, Inc.
Cardiovascular · 4d
Cleared Dec 28, 1976
CENTRAL STATION MONITORING SYSTEM
K761291
Abbott Laboratories
Cardiovascular · 7d
Cleared Dec 13, 1976
MODEL 15050A DIGITAL DISPLAY
K761211
Hewlett-Packard Co.
Cardiovascular · 6d
Cleared Oct 20, 1976
PHYSIOLOGICAL MONITOR (MODEL 870)
K760803
Datascope Corp.
Cardiovascular · 8d
Cleared Sep 16, 1976
PORTABLE CARDIAC MONITOR, ABBY
K760593
Abbott Laboratories
Cardiovascular · 9d
Cleared Jul 20, 1976
PULSE CARDULE (MODEL 1859/1860 ECG)
K760120
Spacelabs, Inc.
Cardiovascular · 22d