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
217–240 of 398
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
EPICARIDA, LE
K872837
Medicomp, Inc.
Cardiovascular · 107d
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 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 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 May 21, 1986
PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III
K860980
Spacelabs, Inc.
Cardiovascular · 71d
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 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 Mar 31, 1986
FUKUDA DENSHI CARDIMAX FCP-211
K860024
Brentwood Instruments, Inc.
Cardiovascular · 87d
Cleared Feb 26, 1986
MEDILOG 2500 SYSTEM
K860078
Oxford Medilog, Inc.
Cardiovascular · 49d