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
289–312 of 341
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 Jul 08, 1980
ABBY II PATIENT MONITOR OR VITAL SIGNS M
K801515
Abbott Medical Electronics Co.
Cardiovascular · 8d
Cleared Apr 10, 1980
D668 & D664 CENTRAL MONITORING SYSTEMS
K800243
Medtel Pty. , Ltd.
Cardiovascular · 65d
Cleared Apr 08, 1980
PULSEOMETER
K800500
Kirklands Sporting Goods Co.
Cardiovascular · 35d
Cleared Dec 19, 1979
CARDIVAN BLOOD PRESSURE MONITOR
K792226
Paramed Technology, Inc.
Cardiovascular · 44d
Cleared Nov 27, 1979
CHRONAEROBIC (CA-1)
K792122
Stanford Scientific, Inc.
Cardiovascular · 33d
Cleared Nov 21, 1979
HEART RATE MONITOR MD-1
K792312
Medical Devices, Inc.
Cardiovascular · 5d
Cleared Nov 13, 1979
AIR-SHIELDS HEART RATE MONITOR
K792117
Narco Air-Shields
Cardiovascular · 18d
Cleared Oct 04, 1979
HEART RATE COMPUTER
K791862
Stanford Assoc., Inc.
Cardiovascular · 10d
Cleared Jun 06, 1979
STRESS TESTING SYSTEM, LATERAL TILTING
K790545
Engineering Dynamics Corp.
Cardiovascular · 78d
Cleared Jun 05, 1979
STRESS TESTING SYSTEM, MULTI-POSITION
K790544
Engineering Dynamics Corp.
Cardiovascular · 75d
Cleared May 01, 1979
AS7 & AS8 MONITORS
K790552
Narco Air-Shields
Cardiovascular · 42d
Cleared Apr 26, 1979
SUBMAX
K790644
Chase Mfg. Co.
Cardiovascular · 27d
Cleared Apr 09, 1979
DAISCOPE & ACCESSORIES
K790506
Simonsen & Weels Eftf.
Cardiovascular · 27d
Cleared Apr 03, 1979
MODEL 78801A PATIENT MONITORS
K790454
Hewlett-Packard Co.
Cardiovascular · 29d
Cleared Mar 06, 1979
MONITOR PLUG-IN MODEL M1106 ECG
K790198
Electronics For Medicine, Inc.
Cardiovascular · 40d
Cleared Feb 28, 1979
MONITOR SCOPES, MODELS 9502, 9503
K790004
C-V Monitors Corp.
Cardiovascular · 57d
Cleared Feb 26, 1979
MONITOR, ELECTROCARDIOSCOPE
K790292
Burdick Corp.
Cardiovascular · 17d
Cleared Jan 15, 1979
PULSETAKER
K782131
Van, Cott, Bagley, Cornwall & Mccarth
Cardiovascular · 19d
Cleared Jan 04, 1979
MONITOR, HEART RATE MODEL 105
K782088
Roche Medical Electronics, Inc.
Cardiovascular · 21d
Cleared Jan 04, 1979
MONITOR, HEART RATE MODEL 103
K782089
Roche Medical Electronics, Inc.
Cardiovascular · 21d
Cleared Oct 15, 1978
MONITOR, HEART RATE
K781166
Cybernetic Medical, Inc.
Cardiovascular · 95d
Cleared Sep 27, 1978
ERM-101
K781407
Cynergy
Cardiovascular · 44d