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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 K903704
Device Name FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
Applicant
Fukuda Denshi USA, Inc.
7102-A 180th Ave. Northeast
Redmond,  WA  98052
Applicant Contact ROBERT J STEURER
Correspondent
Fukuda Denshi USA, Inc.
7102-A 180th Ave. Northeast
Redmond,  WA  98052
Correspondent Contact ROBERT J STEURER
Regulation Number870.1025
Classification Product Code
DSI  
Date Received06/12/1990
Decision Date 09/07/1990
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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