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
337–360 of 398
Cleared Jul 02, 1984
CARDIO EXPRESS 100 HOLTER SCANNER
K840622
Del Mar Avionics
Cardiovascular · 139d
Cleared Jun 05, 1984
LEAP FROG
K834211
Philips Medical Systems (Cleveland), Inc.
Cardiovascular · 183d
Cleared Apr 17, 1984
HOLTER CARDIOGRAPHY SYS 6201
K834397
Instruments For Cardiac Research
Cardiovascular · 125d
Cleared Apr 17, 1984
ALPHA MASS STORAGE CARDULE 1895
K834597
Spacelabs, Inc.
Cardiovascular · 109d
Cleared Jan 27, 1984
HOLTA-MED INFORMER PLAYBACK
K832354
Holta-Med
Cardiovascular · 193d
Cleared Jan 10, 1984
AMBULATORY MONITORING DEVICE
K833162
Oxford Medilog, Inc.
Cardiovascular · 116d
Cleared Dec 01, 1983
BIOSENSOR ASC SYSTEM
K831676
Biosensor Corp.
Cardiovascular · 192d
Cleared Nov 14, 1983
SINGLE BED ARRHYTHMIA MONITOR AM500
K831638
Lifeline Systems, Inc.
Cardiovascular · 175d
Cleared Nov 07, 1983
ARRHYTHMIA III CARDULE #1919
K832693
Spacelabs, Inc.
Cardiovascular · 89d
Cleared Nov 03, 1983
SATURN-24HR. HOLTER SCANNER
K832772
Hittman Medical Systems
Cardiovascular · 79d
Cleared Oct 27, 1983
WLECTROCARDIOGRAPH ECG-7204
K831274
Nihon Kohden America, Inc.
Cardiovascular · 191d
Cleared Jun 18, 1983
CIRCA MED TWO-CHANNEL
K830830
Circadian, Inc.
Cardiovascular · 94d
Cleared Apr 06, 1983
COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13
K823585
Brentwood Instruments, Inc.
Cardiovascular · 121d
Cleared Apr 06, 1983
COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200
K823586
Brentwood Instruments, Inc.
Cardiovascular · 121d
Cleared Mar 31, 1983
SIRECUST 400
K830029
Analogic Corp.
Cardiovascular · 86d
Cleared Mar 24, 1983
ECLIPSE
K830407
Diagnostic Medical Instruments
Cardiovascular · 45d
Cleared Mar 17, 1983
HEARTRATE PLUS ECG CARDULE #1918
K830306
Spacelabs, Inc.
Cardiovascular · 45d
Cleared Feb 28, 1983
EPI CARDIA SYS. - AMBULATORY MONITOR
K830013
Medicomp, Inc.
Cardiovascular · 56d
Cleared Feb 18, 1983
IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS
K830163
Intl. Business Machines
Cardiovascular · 31d
Cleared Dec 15, 1982
ELECTROCARDIOGRAPH INTERPRETER
K822968
Suzuken Co., Ltd.
Cardiovascular · 69d
Cleared Oct 18, 1982
LS6 ARRYTHMIA DISCRIMINATOR
K822616
Life Science Instrumentation, Inc.
Cardiovascular · 49d
Cleared Oct 04, 1982
CARDIO TEHCHANALYZER
K821711
Cardio Technology , Ltd.
Cardiovascular · 117d
Cleared Oct 04, 1982
SERIES 7000 BEDSIDE PATIENT MONITOR
K822718
Marquette Electronics, Inc.
Cardiovascular · 27d
Cleared Sep 28, 1982
MULTIPLE LEAD ARRHYTHMIA MODULE
K822030
Marquette Electronics, Inc.
Cardiovascular · 78d