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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 K121527
Model HS5
Device Name WI-FI BODY SCALE
Applicant
SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD
no. 3. jinping road ya'an
street, nankai district
tianjin, 
Contact yang wang
Regulation Number870.2770
Classification Product Code
MNW  
Date Received05/30/2012
Decision Date 06/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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