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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Body Composition
510(k) Number K112951
Device Name BODY ANALYSIS SCALE
Applicant
Shenzhen Healthcare Electronic Technology Co., Ltd.
77325 Joyce Way
Echo,  OR  97826
Applicant Contact CHARLIE MACK
Correspondent
Shenzhen Healthcare Electronic Technology Co., Ltd.
77325 Joyce Way
Echo,  OR  97826
Correspondent Contact CHARLIE MACK
Regulation Number870.2770
Classification Product Code
MNW  
Date Received10/04/2011
Decision Date 11/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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