DSI · Class II · 21 CFR 870.1025

FDA Product Code DSI: Detector And Alarm, Arrhythmia

Leading manufacturers include Siemens Medical Solutions USA, Inc., Fukuda Denshi USA, Inc. and Nihon Kohden America, Inc..

398
Total
398
Cleared
150d
Avg days
1976
Since
398 devices
169–192 of 398
Cleared Apr 30, 1986
DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST
K860470
Del Mar Avionics
Cardiovascular · 83d
Cleared Apr 30, 1986
DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER
K860471
Del Mar Avionics
Cardiovascular · 83d
Cleared Apr 29, 1986
SPACELABS MEDICAL WORKSTATION
K860834
Spacelabs, Inc.
Cardiovascular · 55d
Cleared Mar 31, 1986
MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL
K853669
Hewlett-Packard Co.
Cardiovascular · 209d
Cleared Feb 26, 1986
MEDILOG 2500 SYSTEM
K860078
Oxford Medilog, Inc.
Cardiovascular · 49d
Cleared Feb 26, 1986
MEDILOG 4500 SYSTEM
K860079
Oxford Medilog, Inc.
Cardiovascular · 49d
Cleared Feb 12, 1986
FUKUDA DENSHI ALTHUS 5100 PATIENT MONITORING/DATA
K855094
Fukuda Denshi USA, Inc.
Cardiovascular · 51d
Cleared Dec 09, 1985
MEDILOG M6
K852892
Oxford Medilog, Inc.
Cardiovascular · 153d
Cleared Nov 14, 1985
FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR
K853352
Fukuda Denshi USA, Inc.
Cardiovascular · 94d
Cleared Oct 11, 1985
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
K853213
Fukuda Denshi USA, Inc.
Cardiovascular · 144d
Cleared Sep 12, 1985
MODEL 78560A CENTRAL STATION PATIENT INFO SYS
K852514
Hewlett-Packard Co.
Cardiovascular · 92d
Cleared Jul 30, 1985
LIFESCOPE 8 DEC-8108A AND DEC-8204A
K852270
Nihon Kohden America, Inc.
Cardiovascular · 63d
Cleared Jul 29, 1985
MORTARA INSTRUMENT MODEL EL-1
K851702
Mortara Instrument, Inc.
Cardiovascular · 96d
Cleared Jul 26, 1985
MEDILOG M3
K852883
Oxford Medilog, Inc.
Cardiovascular · 17d
Cleared Jul 26, 1985
MEDILOG M1
K852884
Oxford Medilog, Inc.
Cardiovascular · 17d
Cleared Jun 11, 1985
OXFORD VDT-40 DISPLAY TERMINAL
K852207
Oxford Medilog, Inc.
Cardiovascular · 21d
Cleared Apr 10, 1985
FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES
K850897
Fukuda Denshi USA, Inc.
Cardiovascular · 37d
Cleared Feb 01, 1985
ARRHYTHMIA SYSTEM AC-11
K841084
Fukuda Denshi USA, Inc.
Cardiovascular · 325d
Cleared Jan 10, 1985
HORIZON ECG SYSTEM
K823844
Beckman Instruments, Inc.
Cardiovascular · 751d
Cleared Nov 20, 1984
SERVOMED ARRHYCOMP CENTRAL MONITOR SYS
K840899
Litton Medical Electronics
Cardiovascular · 266d
Cleared Oct 18, 1984
PEDIATRIC DIAG. CRITERIA OPTION 5600C
K841416
Hewlett-Packard Co.
Cardiovascular · 196d
Cleared Oct 18, 1984
SPACELABS ALPHA PC PATIENT COMPUTER
K842616
Spacelabs, Inc.
Cardiovascular · 105d
Cleared Oct 18, 1984
ARRHYTHMIA CENTRAL OCC-7101
K843287
Nihon Kohden America, Inc.
Cardiovascular · 58d
Cleared Oct 04, 1984
SPACELABS ICR ARRHYTHMIA MASTER I HOLTER
K842640
Spacelabs, Inc.
Cardiovascular · 86d