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FDA 510(k) Application Details - K131394
Device Classification Name
Analyzer, Body Composition
More FDA Info for this Device
510(K) Number
K131394
Device Name
Analyzer, Body Composition
Applicant
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
NO.1 FANGHUA STREET, HI-TECH DISTRICT
CHENGDU, SICHUAN 610041 CN
Other 510(k) Applications for this Company
Contact
LEO WANG
Other 510(k) Applications for this Contact
Regulation Number
870.2770
More FDA Info for this Regulation Number
Classification Product Code
MNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/15/2013
Decision Date
09/18/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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