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..

341
Total
341
Cleared
123d
Avg days
1976
Since
341 devices
145–168 of 341
Cleared Nov 21, 1986
LIFE-WATCH MONITOR LT-8
K863534
Computerized Medical Systems, Inc.
Cardiovascular · 71d
Cleared Sep 12, 1986
CARDIAN II CR45A
K861621
Cardiac Recorders, Ltd.
Cardiovascular · 136d
Cleared Jun 16, 1986
ERG 550 ERGOMETER BICYCLE
K854491
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 16, 1986
ERG 551 ERGOMETER, BICYCLE
K854492
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 16, 1986
ERG 555 COUCH ERGOMETER
K854493
Robert Bosch Corp.
Cardiovascular · 216d
Cleared Jun 16, 1986
PHYSIO-DYNE ECG/HR 3
K854847
Physio-Dyne Industrument Corp.
Cardiovascular · 194d
Cleared Jun 02, 1986
CARDIOCAP MONITOR
K853953
Instrumentarium Corp.
Cardiovascular · 250d
Cleared May 09, 1986
VICKERS MEDICAL MODEL 271 HEART RATE MONITOR
K854597
Vickers , Ltd.
Cardiovascular · 172d
Cleared Apr 17, 1986
BIOMECCA CENTRAL CS1
K854639
Biomecca Australia , Ltd.
Cardiovascular · 149d
Cleared Mar 26, 1986
PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM
K855125
Honeywell, Inc.
Cardiovascular · 93d
Cleared Mar 13, 1986
PE-3000 PULSE RATE MONITOR
K854198
Quantum Life Systems, Inc.
Cardiovascular · 149d
Cleared Mar 11, 1986
PATIENT MONITOR PB240
K853318
Puritan Bennett Corp.
Cardiovascular · 216d
Cleared Mar 11, 1986
SIRECUST 341 AND 341R
K854881
Siemens Medical Solutions USA, Inc.
Cardiovascular · 95d
Cleared Feb 28, 1986
MOLDTEC STIMULATOR
K853757
Moldtec, Inc.
Cardiovascular · 172d
Cleared Jan 07, 1986
CD-100 CARDIAC MONITOR
K854041
Cardio Display Corp.
Cardiovascular · 97d
Cleared Dec 11, 1985
CARDIORATER CR 51
K853673
Cardiac Recorders, Ltd.
Cardiovascular · 98d
Cleared Nov 19, 1985
CARDIORATER CR7
K852910
Cardiac Recorders, Ltd.
Cardiovascular · 133d
Cleared Nov 14, 1985
CR5 CARDIAC MONITOR
K852887
Cardiac Recorders, Ltd.
Cardiovascular · 128d
Cleared Aug 19, 1985
ECS 502
K840717
Robert Bosch Corp.
Cardiovascular · 549d
Cleared Aug 19, 1985
VSM MODELS A & B
K851916
Physio-Control Corp.
Cardiovascular · 109d
Cleared Jul 24, 1985
COACH TM- THE AEROBIC FITNESS MONITOR
K851335
Biotechnology, Inc.
Cardiovascular · 112d
Cleared Jun 28, 1985
CARDIAC EVENT RECORDER
K843533
Cryo2 Corp.
Cardiovascular · 294d
Cleared Jun 06, 1985
MODEL 78353B
K842817
Hewlett-Packard Co.
Cardiovascular · 323d
Cleared Jun 06, 1985
BEDSIDE PATIENT MONITOR W/MODULES
K850619
Midwest Analog & Digital, Inc.
Cardiovascular · 111d