DSI · Class II · 21 CFR 870.1025

FDA Product Code DSI: Detector And Alarm, Arrhythmia

Leading manufacturers include Siemens Medical Solutions USA, Inc., Hewlett-Packard Co. and Medtronic, Inc..

398
Total
398
Cleared
150d
Avg days
1976
Since
398 devices
49–72 of 398
Cleared May 10, 1995
1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED
K945384
Siemens Medical Solutions USA, Inc.
Cardiovascular · 188d
Cleared Apr 10, 1995
SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS
K933177
Siemens Medical Solutions USA, Inc.
Cardiovascular · 649d
Cleared Apr 10, 1995
SC 6000/ SC 6000P/ R50
K944350
Siemens Medical Solutions USA, Inc.
Cardiovascular · 216d
Cleared Jul 20, 1993
CC ARHYTHMIS MONITORING OPTION
K923747
Hewlett-Packard Co.
Cardiovascular · 376d
Cleared Oct 31, 1991
HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS
K913451
Hewlett-Packard Co.
Cardiovascular · 90d
Cleared Apr 26, 1991
MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A
K910490
Hewlett-Packard Co.
Cardiovascular · 80d
Cleared Apr 22, 1991
MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION
K910291
Hewlett-Packard Co.
Cardiovascular · 89d
Cleared Mar 06, 1989
SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL
K884106
Siemens Medical Solutions USA, Inc.
Cardiovascular · 158d
Cleared Mar 31, 1986
MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL
K853669
Hewlett-Packard Co.
Cardiovascular · 209d
Cleared Sep 12, 1985
MODEL 78560A CENTRAL STATION PATIENT INFO SYS
K852514
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Jan 10, 1985
HORIZON ECG SYSTEM
K823844
Beckman Instruments, Inc.
Cardiovascular · 751d
Cleared Oct 18, 1984
PEDIATRIC DIAG. CRITERIA OPTION 5600C
K841416
Hewlett-Packard Co.
Cardiovascular · 196d
Cleared Apr 15, 1982
ALGORITHM OF THE ARRHYTHMIA MON. SYS
K820477
Hewlett-Packard Co.
Cardiovascular · 52d
Cleared Dec 29, 1981
MICRO-PREPROCESSOR UNIT
K812914
General Electric Co.
Cardiovascular · 71d
Cleared Feb 27, 1981
GUARDIAN MONITOR (CARDIOVASCULAR)
K803282
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 60d
Cleared Sep 26, 1980
ECG RECALL & EDIT PRODUCT VERSION-A3601
K802103
General Electric Co.
Cardiovascular · 23d
Cleared Aug 27, 1980
MICRO-PROCESSOR UNIT #A3600AC
K801762
General Electric Co.
Cardiovascular · 30d
Cleared Aug 28, 1979
MODEL 78520A ARRHYTHMIA MONITORING SYS
K791487
Hewlett-Packard Co.
Cardiovascular · 22d
Cleared Jan 12, 1978
ARRHYTHMIA MODULE
K772360
General Electric Co.
Cardiovascular · 16d