FDA 510(k) Application Details - K073656

Device Classification Name Oximeter, Tissue Saturation

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510(K) Number K073656
Device Name Oximeter, Tissue Saturation
Applicant HYPERMED, INC.
11 MYSTIC AVE.
WINCHESTER, MA 01890-2920 US
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Contact CHAS BURR
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Regulation Number 870.2700

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Classification Product Code MUD
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Date Received 12/26/2007
Decision Date 01/25/2008
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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