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
289–312 of 398
Cleared May 02, 1986
595 ARRHYTHMIA MONITORING SYSTEM
K852250
Burdick Corp.
Cardiovascular · 344d
Cleared May 02, 1986
SCM-400 HOLTER SYSTEM
K860950
Fukuda Denshi USA, Inc.
Cardiovascular · 51d
Cleared May 02, 1986
BECHLER MEDICAL, MODEL 5000,THE WIZ HOLTER SCANNER
K861240
Mountain View Medical
Cardiovascular · 30d
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 Apr 23, 1986
MODEL E 600 ELECTROCARDIOGRAPH
K860767
Kone Instruments, Inc.
Cardiovascular · 51d
Cleared Mar 31, 1986
MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL
K853669
Hewlett-Packard Co.
Cardiovascular · 209d
Cleared Mar 31, 1986
FUKUDA DENSHI CARDIMAX FCP-211
K860024
Brentwood Instruments, Inc.
Cardiovascular · 87d
Cleared Mar 31, 1986
PRODIGY AND PRODIGY PLUS
K860167
Cardiodata Corp.
Cardiovascular · 73d
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 Jan 27, 1986
CUSTO PORT 24-H ECG AMBULATORY RECORDER
K854115
Versacor, Inc.
Cardiovascular · 111d
Cleared Jan 08, 1986
PREVIEW XT
K854282
Cambridge Medical Instruments, Inc.
Cardiovascular · 76d
Cleared Dec 09, 1985
MEDILOG M6
K852892
Oxford Medilog, Inc.
Cardiovascular · 153d
Cleared Dec 04, 1985
CARDIAC COMMUNICATOR 2000
K852654
Creative Medical, Inc.
Cardiovascular · 163d
Cleared Nov 14, 1985
PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM
K852968
Personal Computers For Medicine, Inc.
Cardiovascular · 122d
Cleared Nov 14, 1985
FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR
K853352
Fukuda Denshi USA, Inc.
Cardiovascular · 94d
Cleared Nov 05, 1985
COMPAS 1
K853209
Cardiac Care Units, Inc.
Cardiovascular · 97d
Cleared Oct 11, 1985
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
K853213
Fukuda Denshi USA, Inc.
Cardiovascular · 144d
Cleared Oct 02, 1985
CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO
K851517
Circadian, Inc.
Cardiovascular · 170d
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