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
49–72 of 339
Cleared Aug 07, 1996
CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM
K960544
Nasiff Assoc., Inc.
Cardiovascular · 182d
Cleared Apr 18, 1996
OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM
K950688
Safety Tek Corp.
Cardiovascular · 429d
Cleared Oct 19, 1995
EAGLE 3000 PATIENT MONITOR
K952474
Marquette Electronics, Inc.
Cardiovascular · 142d
Cleared May 12, 1995
ECG MONITOR
K944262
Fukuda Denshi USA, Inc.
Cardiovascular · 255d
Cleared Apr 12, 1995
MERCURY
K940081
Mennen Medical, Inc.
Cardiovascular · 460d
Cleared Sep 21, 1994
LIONHEART 3 MULTI-PARAMETER SIMULATOR
K944257
Bio-Tek Instruments, Inc.
Cardiovascular · 21d
Cleared Jun 23, 1993
ESCORT 100/300 SERIES B PATIENT MONITORS
K930004
Medical Data Electronics
Cardiovascular · 170d
Cleared Feb 05, 1993
SYSTEM ATHENA, MODIFICATION
K911611
S & W Medico Teknik
Cardiovascular · 668d
Cleared Nov 09, 1992
HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING
K921194
Hewlett-Packard Co.
Cardiovascular · 242d
Cleared Dec 31, 1991
MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED
K910665
Ge Medical Systems Information Technologies
Cardiovascular · 323d
Cleared Dec 05, 1991
SYSTEM ATHENA - PRODUCT ENHANCEMENTS
K912049
S & W Medico Teknik
Cardiovascular · 240d
Cleared Oct 15, 1991
DATASCOPE PASSPORT MONITOR
K911598
Datascope Corp.
Cardiovascular · 189d
Cleared Aug 29, 1991
EDENTEC MODEL 3711 DIGITAL RECORDER
K910870
Edentec Corp.
Cardiovascular · 181d
Cleared Jul 30, 1991
507 NON-INVASIVE VITAL SIGNS MONITOR
K910852
Criticare Systems, Inc.
Cardiovascular · 153d
Cleared Jul 17, 1991
VITALMAX 2100/2200
K905274
Pace Tech, Inc.
Cardiovascular · 244d
Cleared Jul 10, 1991
HORIZON XL
K911616
Mennen Medical, Inc.
Cardiovascular · 90d
Cleared Jun 11, 1991
HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A
K911139
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Feb 07, 1991
WEP-8430A TELEMETRY CENTRAL STATION
K904696
Nihon Kohden America, Inc.
Cardiovascular · 176d
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 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