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
265–288 of 398
Cleared Jan 07, 1988
CARDIOFAX-V ECG-8110A
K873874
Nihon Kohden America, Inc.
Cardiovascular · 107d
Cleared Dec 18, 1987
FUKUDA DENSHI MODEL FCP-231
K874768
Fukuda Denshi USA, Inc.
Cardiovascular · 29d
Cleared Nov 23, 1987
MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM
K873680
Oxford Medilog, Inc.
Cardiovascular · 70d
Cleared Nov 04, 1987
THE EXPERT MODELS RTS 2000 AND RTS 2000H
K862947
Ocg Technology, Inc.
Cardiovascular · 456d
Cleared Nov 04, 1987
EPICARIDA, LE
K872837
Medicomp, Inc.
Cardiovascular · 107d
Cleared Oct 20, 1987
PATHFINDER 3, AUTO SURVEYOR AND SURVEYOR
K871344
Reynolds Medical , Ltd.
Cardiovascular · 197d
Cleared Oct 06, 1987
MODEL MR-45 AMBULATORY HOLTER MONITOR
K872497
Oxford Medilog, Inc.
Cardiovascular · 104d
Cleared Sep 30, 1987
LIFESCOPE 12, BSM 8500A PATIENT MONITOR
K872241
Nihon Kohden America, Inc.
Cardiovascular · 111d
Cleared Sep 01, 1987
HOLTER ST SYSTEM, MODEL NO. 5000-20
K871389
Holter Data Services
Cardiovascular · 147d
Cleared Jun 12, 1987
CARDIO-MEGA SYSTEM
K871890
Grandcor Medical Systems
Cardiovascular · 28d
Cleared May 22, 1987
CIRCAMED FULL DISCLOSURE SYSTEM
K871251
Circadian, Inc.
Cardiovascular · 53d
Cleared Mar 24, 1987
FUKUDA DENSHI MODEL FCP-15
K871025
Fukuda Denshi USA, Inc.
Cardiovascular · 8d
Cleared Mar 10, 1987
CARDIOFAX-V ECG-8240A
K865030
Nihon Kohden America, Inc.
Cardiovascular · 77d
Cleared Mar 10, 1987
CARDIOFAX-V ECG-834OA
K865032
Nihon Kohden America, Inc.
Cardiovascular · 77d
Cleared Mar 03, 1987
PLURIMUS CARDIAC EVALUATION SYSTEM
K864401
Vivix Corp.
Cardiovascular · 117d
Cleared Dec 10, 1986
Q-SCAN II AND Q-SCAN III
K864149
Quinton, Inc.
Cardiovascular · 49d
Cleared Dec 05, 1986
EPICARDIA, PC/FD
K863643
Medicomp, Inc.
Cardiovascular · 78d
Cleared Nov 25, 1986
SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1
K864506
Spacelabs, Inc.
Cardiovascular · 11d
Cleared Nov 24, 1986
SPACELABS ARRHYTHMIA NET (TM) LEVEL 2
K864505
Spacelabs, Inc.
Cardiovascular · 10d
Cleared Nov 20, 1986
CASE 12
K862316
Marquette Electronics, Inc.
Cardiovascular · 155d
Cleared Nov 20, 1986
MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM
K863724
Oxford Medilog, Inc.
Cardiovascular · 58d
Cleared Oct 06, 1986
Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR
K863159
Quinton, Inc.
Cardiovascular · 49d
Cleared Jul 01, 1986
CARDIO PORT 500 24-H ECG AMBULATORY MONITOR SYSTEM
K862375
Grandcor Medical Systems
Cardiovascular · 7d
Cleared May 21, 1986
PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III
K860980
Spacelabs, Inc.
Cardiovascular · 71d