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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K823844
Device Name HORIZON ECG SYSTEM
Applicant
Beckman Instruments, Inc.
P.O. Box 3100
Fullerton,  CA  92634
Applicant Contact JACK SOROKIN
Correspondent
Beckman Instruments, Inc.
P.O. Box 3100
Fullerton,  CA  92634
Correspondent Contact JACK SOROKIN
Regulation Number870.1025
Classification Product Code
DSI  
Date Received12/21/1982
Decision Date 01/10/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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