FDA 510(k) Application Details - K081238

Device Classification Name Oximeter, Reprocessed

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510(K) Number K081238
Device Name Oximeter, Reprocessed
Applicant ASCENT HEALTHCARE SOLUTIONS
10232 SOUTH 51ST ST.
PHOENIX, AZ 85044 US
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Contact KATIE BRAY
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Regulation Number 870.2700

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Classification Product Code NLF
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Date Received 05/01/2008
Decision Date 07/29/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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