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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K112521
Device Name FUKUDA DENSHI VASERA MODEL VS-1500
Applicant
Fukuda Denshi USA, Inc.
17725 NE 65th St., Bldg. C
Redmond,  WA  98052
Applicant Contact DOUG BLAKELY
Correspondent
Fukuda Denshi USA, Inc.
17725 NE 65th St., Bldg. C
Redmond,  WA  98052
Correspondent Contact DOUG BLAKELY
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DQC   JOO  
Date Received08/31/2011
Decision Date 12/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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