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
313–336 of 398
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 Jul 11, 1985
KENZ 80Z MARK II
K843731
Suzuken Co., Ltd.
Cardiovascular · 290d
Cleared Jun 11, 1985
OXFORD VDT-40 DISPLAY TERMINAL
K852207
Oxford Medilog, Inc.
Cardiovascular · 21d
Cleared Apr 10, 1985
SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A
K844791
Analogic Corp.
Cardiovascular · 121d
Cleared Apr 10, 1985
FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES
K850897
Fukuda Denshi USA, Inc.
Cardiovascular · 37d
Cleared Apr 03, 1985
PROGRAMMABLE PATIENT SIMULATOR
K844464
Ramford Labs
Cardiovascular · 134d
Cleared Mar 01, 1985
BRENTWOOD EZ SCAN 200 AMBULATORY ECG
K842976
Brentwood Instruments, Inc.
Cardiovascular · 214d
Cleared Feb 07, 1985
QUIKPAGE ARRHYTHMIA REPORT GENERATOR
K841083
Agilent Technologies
Cardiovascular · 331d
Cleared Feb 01, 1985
ARRHYTHMIA SYSTEM AC-11
K841084
Fukuda Denshi USA, Inc.
Cardiovascular · 325d
Cleared Feb 01, 1985
CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM
K850136
Cardio Data
Cardiovascular · 18d
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 Nov 19, 1984
DOCUMENTOR
K842715
Life Technology
Cardiovascular · 130d
Cleared Nov 16, 1984
PERSONAL CL SINGLE-CHANNEL ELECTROCAR
K842123
Parexel Intl. Corp.
Cardiovascular · 171d
Cleared Oct 26, 1984
AEGIS AMBULATORY MONITORING SYSTEM
K843503
Aegis Medical Systems, Inc.
Cardiovascular · 50d
Cleared Oct 22, 1984
EPICARDIA, PC
K843513
Medicomp, Inc.
Cardiovascular · 46d
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
Cleared Aug 28, 1984
LIFESCOPE 6 OEC-6201
K841500
Nihon Kohden America, Inc.
Cardiovascular · 140d
Cleared Jul 27, 1984
MONITOR ONE
K841172
Qmed, Inc.
Cardiovascular · 130d