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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 K020084
Device Name FUKUDA DENSHI DYNASCOPE MODEL DS-5700
Applicant
Fukuda Denshi USA, Inc.
17725 NE 65th St.
Bldg. C
Redmond,  WA  98052 -4911
Applicant Contact LARRY D WALKER
Correspondent
Fukuda Denshi USA, Inc.
17725 NE 65th St.
Bldg. C
Redmond,  WA  98052 -4911
Correspondent Contact LARRY D WALKER
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Code
MHX  
Date Received01/10/2002
Decision Date 02/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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