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FDA 510(k) Application Details - K122976
Device Classification Name
Analyzer, Body Composition
More FDA Info for this Device
510(K) Number
K122976
Device Name
Analyzer, Body Composition
Applicant
SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS TE
77325 JOYCE WAY
ECHO, OR 97826 US
Other 510(k) Applications for this Company
Contact
CHARLIE MACK
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
09/26/2012
Decision Date
01/04/2013
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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