FDA 510(k) Application Details - K123228

Device Classification Name Analyzer, Body Composition

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510(K) Number K123228
Device Name Analyzer, Body Composition
Applicant BIOSPACE CORPORATION LIMITED
8870 RAVELLO CT
NAPLES, FL 34114 US
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Contact DANIEL KAMM
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Regulation Number 870.2770

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Classification Product Code MNW
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Date Received 10/15/2012
Decision Date 03/08/2013
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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