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
217–240 of 341
Cleared Oct 31, 1983
PATIENT MONITOR #RM-100
K831817
Honeywell, Inc.
Cardiovascular · 147d
Cleared Oct 31, 1983
CENTRAL STATION MONITOR CSM-100
K831818
Honeywell, Inc.
Cardiovascular · 147d
Cleared Oct 31, 1983
SERVOMED COMPACT MONITOR 181/10105002
K832018
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 26, 1983
LME HEART-RATE MONITOR
K832016
Litton Medical Electronics
Cardiovascular · 125d
Cleared Oct 26, 1983
SERVOMED BASIC BEDSIDE UNIT - VARIOUS
K832024
Litton Medical Electronics
Cardiovascular · 125d
Cleared Oct 26, 1983
SERVOMED BASIC BEDSIDE UNIT SMS 108 W/
K832026
Litton Medical Electronics
Cardiovascular · 125d
Cleared Oct 26, 1983
SERVOMED STANDARD SMS 104
K832041
Litton Medical Electronics
Cardiovascular · 124d
Cleared Oct 19, 1983
PATIENT MONITOR 788 33A
K831943
Hewlett-Packard Co.
Cardiovascular · 125d
Cleared Oct 19, 1983
PATIENT MONITOR #78832A
K831944
Hewlett-Packard Co.
Cardiovascular · 125d
Cleared Oct 14, 1983
AS 1740 INTERFACE MODULE
K831428
Narco Scientific
Cardiovascular · 164d
Cleared Sep 29, 1983
BIOCHECK PEC-108 PROGRAM-PULSE MONITOR
K831752
Biotechnology, Inc.
Cardiovascular · 120d
Cleared Sep 29, 1983
PATIENT MONITOR #78353A
K831787
Hewlett-Packard Co.
Cardiovascular · 118d
Cleared Sep 12, 1983
AIR SHIELDS AS-100 MONIORING SYS-AS105
K831430
Narco Scientific
Cardiovascular · 132d
Cleared Aug 12, 1983
PHYSIOLOGICAL MONITOR #902
K831578
Novametrix Medical Systems, Inc.
Cardiovascular · 87d
Cleared Jul 07, 1983
VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR
K830916
Bib, Inc.
Cardiovascular · 107d
Cleared Jun 22, 1983
GOULD MODEL IM3000-IM3100 BATTERY POWER
K830885
Gould, Inc.
Cardiovascular · 93d
Cleared Jun 15, 1983
CENTRAL STATION DISPLAY/RECORDER MATRIX
K830517
Marquette Electronics, Inc.
Cardiovascular · 118d
Cleared Jun 08, 1983
VITAL SIGNS MONITOR 2
K830587
Physio-Control Corp.
Cardiovascular · 105d
Cleared May 25, 1983
MODEL 515 NEO-TRAK NEONATAL MONITOR
K823904
Ge Medical Systems Information Technologies
Cardiovascular · 148d
Cleared May 18, 1983
CABINET FOR MULTIPLE FUNCTION BLOCKS
K830795
Electronics For Medicine, Inc.
Cardiovascular · 65d
Cleared May 09, 1983
PRESSURE FUNCTION BLOCK FOR BLOOD PRESS
K830779
Honeywell, Inc.
Cardiovascular · 59d
Cleared Apr 14, 1983
ELECTRONIC EXERCISE #313-PULSE RATE
K830282
Walton Manufacturer Co.
Cardiovascular · 78d
Cleared Mar 24, 1983
CENTRAL STATION 590
K830432
Kone Instruments, Inc.
Cardiovascular · 43d
Cleared Mar 24, 1983
PATIENT MONITOR 575
K830433
Kone Instruments, Inc.
Cardiovascular · 43d