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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
NO. 3. JINPING ROAD YA'AN
STREET, NANKAI DISTRICT
TIANJIN,  CN 300190
Applicant Contact YANG WANG
Correspondent
SHENZHEN HEALTHCARE ELECTRONIC TECHNOLOGY CO. LTD
NO. 3. JINPING ROAD YA'AN
STREET, 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
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