FDA 510(k) Application Details - K120896

Device Classification Name Analyzer, Body Composition

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510(K) Number K120896
Device Name Analyzer, Body Composition
Applicant ANDON HEALTH CO., LTD
No. 3 Jin Ping Street,Ya An Road,
NANKAI DISTRICT
TIANJIN 300190 CN
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Contact LIU YI
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Regulation Number 870.2770

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Classification Product Code MNW
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Date Received 03/26/2012
Decision Date 07/26/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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