FDA 510(k) Application Details - K082147

Device Classification Name Ultrasonic Body Composition Analyzer

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510(K) Number K082147
Device Name Ultrasonic Body Composition Analyzer
Applicant INTELAMETRIX, INC
6246 PRESTON AVENUE
LIVERMORE, CA 94551 US
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Contact HEIDI STARK
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Regulation Number 870.2770

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Classification Product Code OMV
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Date Received 07/30/2008
Decision Date 03/20/2009
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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