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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
Device Name WI-FI BODY SCALE
Applicant
Shenzhen Healthcare Electronic Technology Co., Ltd.
# 3. Jinping Rd. Ya'An
St., Nankai District
Tianjin,  CN 300190
Applicant Contact YANG WANG
Correspondent
Shenzhen Healthcare Electronic Technology Co., Ltd.
# 3. Jinping Rd. Ya'An
St., Nankai District
Tianjin,  CN 300190
Correspondent Contact YANG WANG
Regulation Number870.2770
Classification Product Code
MNW  
Date Received05/23/2012
Decision Date 06/28/2012
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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