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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 K122976
Device Name BODY FAT SCALE MODEL SF-371
Applicant
Shenzhen Belter Health Measurement and Analysis TE
77325 Joyce Way
Echo,  OR  97826
Applicant Contact CHARLIE MACK
Correspondent
Shenzhen Belter Health Measurement and Analysis TE
77325 Joyce Way
Echo,  OR  97826
Correspondent Contact CHARLIE MACK
Regulation Number870.2770
Classification Product Code
MNW  
Date Received09/26/2012
Decision Date 01/04/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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