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
73–96 of 341
Cleared Mar 10, 1995
PULSE HEART RATE MONITOR
K943243
Sensor Dynamics, Inc.
Cardiovascular · 247d
Cleared Nov 01, 1994
K3 SYSTEM
K934644
Astro-Med, Inc.
Cardiovascular · 398d
Cleared Oct 17, 1994
PAM CARDIAC MONITOR
K934684
Technology Transfer, Inc.
Cardiovascular · 382d
Cleared Sep 21, 1994
LIONHEART 3 MULTI-PARAMETER SIMULATOR
K944257
Bio-Tek Instruments, Inc.
Cardiovascular · 21d
Cleared Jul 06, 1994
OMNI-CENTRAL STATION MONITOR
K936051
Invivo Research, Inc.
Cardiovascular · 198d
Cleared May 04, 1994
520 DISPLAY DRIVER- STATUS I
K926298
Vidco, Inc.
Cardiovascular · 506d
Cleared Jan 18, 1994
MEDSIM 300 PATIENT SIMULATOR
K935817
Dynatech/Nevada, Inc.
Cardiovascular · 47d
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 Mar 27, 1992
MODIFIED BIOLOG
K915624
Micromedical Industries, Ltd.
Cardiovascular · 113d
Cleared Mar 09, 1992
GYMMAN
K920099
Lumiscope Co., Inc.
Cardiovascular · 60d
Cleared Dec 31, 1991
MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED
K910665
Ge Medical Systems Information Technologies
Cardiovascular · 323d
Cleared Dec 30, 1991
KELLER CARDIAC MONITOR MEDIL KMS870
K914576
Keller Medical Specialties Products, Inc.
Cardiovascular · 76d
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 Oct 09, 1991
TRU-VIEW MULTI-CHANNEL DISPLAY
K912008
General Devices
Cardiovascular · 156d
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 18, 1991
FUTURECARE CARELYNK IV SYSTEM
K903512
Futurecare Systems, Inc.
Cardiovascular · 349d
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 May 08, 1991
PROPAQ 102EL, 104EL AND 106EL
K910882
Protocol Systems, Inc.
Cardiovascular · 68d