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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 K841084
Device Name ARRHYTHMIA SYSTEM AC-11
Applicant
Fukuda Denshi USA, Inc.
11232 120th. Ave. Ne
Kirkland,  WA  98033
Applicant Contact ROBERT STEURER
Correspondent
Fukuda Denshi USA, Inc.
11232 120th. Ave. Ne
Kirkland,  WA  98033
Correspondent Contact ROBERT STEURER
Regulation Number870.1025
Classification Product Code
DSI  
Date Received03/13/1984
Decision Date 02/01/1985
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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