FDA 510(k) Application Details - K073146

Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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510(K) Number K073146
Device Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant BIOMEDIX, INC.
4215 WHITE BEAR PKWY.
SUITE 200
VADNAIS HEIGHTS, MN 55110 US
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Contact WILLIAM ROGERS
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Regulation Number 870.2780

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Classification Product Code JOM
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Date Received 11/08/2007
Decision Date 11/21/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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