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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
Original Applicant
SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD
no. 3. jinping road ya'an
street, nankai district
tianjin,  CH 300190
Original 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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