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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 K121971
Model WBS01
Device Name WITHINGS, SMART BODY SCALE
Original Applicant
ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD.
no. 1 fanghua street
hi-tech district
chengdu, sichuan,  CH 610041
Original Contact leo wang
Regulation Number870.2770
Classification Product Code
MNW  
Date Received07/05/2012
Decision Date 09/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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