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
97–120 of 341
Cleared Feb 07, 1991
WEP-8430A TELEMETRY CENTRAL STATION
K904696
Nihon Kohden America, Inc.
Cardiovascular · 176d
Cleared Dec 20, 1990
CARDIOMATIC MODEL MSC-2001
K904353
Medical Systems Corp.
Cardiovascular · 87d
Cleared Aug 23, 1990
MORTARA INSTRUMENT MODEL ELI 50
K902652
Mortara Instrument, Inc.
Cardiovascular · 69d
Cleared Jul 18, 1990
VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE
K900451
Pace Tech, Inc.
Cardiovascular · 169d
Cleared Jul 13, 1990
CARDIOMATIC MODEL MSC-1001
K902608
Medical Systems Corp.
Cardiovascular · 31d
Cleared May 17, 1990
PCI MODEL 2041-PC TELEMETRY MONITOR
K901031
Accucore, Inc.
Cardiovascular · 72d
Cleared Apr 20, 1990
TYPE 9040/NEO
K896699
S & W Medico Teknik
Cardiovascular · 143d
Cleared Apr 20, 1990
TYPE 9140/NEO
K896700
S & W Medico Teknik
Cardiovascular · 143d
Cleared Apr 19, 1990
MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL
K901034
Nihon Kohden America, Inc.
Cardiovascular · 44d
Cleared Apr 10, 1990
MODEL M1175A/M1176A WITH ST SEGMENT MONITORING
K900032
Hewlett-Packard Co.
Cardiovascular · 98d
Cleared Apr 04, 1990
MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM
K895801
Marquette Electronics, Inc.
Cardiovascular · 188d
Cleared Mar 19, 1990
BIOLOG
K895534
Micromedical
Cardiovascular · 187d
Cleared Mar 06, 1990
CARDIOCAP(TM) CT-104 MONITOR
K897080
Datex Division Instrumentarium Corp.
Cardiovascular · 75d
Cleared Oct 03, 1989
ERGOMED 840/ERGOMED 840L
K885085
Burdick Corp.
Cardiovascular · 298d
Cleared Oct 02, 1989
MODEL DS-504 DYNASCOPE PATIENT MONITOR
K893405
Fukuda Denshi USA, Inc.
Cardiovascular · 153d
Cleared Oct 02, 1989
TYPE 9140 (SYSTEM ATHENA)
K894699
S & W Medico Teknik
Cardiovascular · 70d
Cleared Oct 02, 1989
TYPE PDU/CDU 9040 (SYSTEM ATHENA)
K894700
S & W Medico Teknik
Cardiovascular · 70d
Cleared Sep 18, 1989
NR5000 E.C.G. AND PULSE OXIMETER MONITOR
K894919
Nirad , Ltd.
Cardiovascular · 47d
Cleared Aug 25, 1989
PULSE TIME PRODUCTS LIMITED, PM-2
K892794
Pulse Time Products, Ltd.
Cardiovascular · 130d
Cleared Aug 25, 1989
PULSE TIME PRODUCTS LIMITED, PM-3
K892795
Pulse Time Products, Ltd.
Cardiovascular · 130d
Cleared Jun 22, 1989
BP-8800 BLOOD PRESSURE MONITOR
K890876
Colin Medical Instruments Corp.
Cardiovascular · 121d
Cleared Jun 22, 1989
HORIZON CENTRAL STATION
K892066
Mennen Medical, Inc.
Cardiovascular · 84d
Cleared May 23, 1989
HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S
K892006
Healthdyne, Inc.
Cardiovascular · 56d
Cleared May 19, 1989
THE COACH
K884804
Promark, Inc.
Cardiovascular · 183d