FDA 510(k) Application Details - K041867

Device Classification Name Oximeter, Reprocessed

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510(K) Number K041867
Device Name Oximeter, Reprocessed
Applicant HYGIA HEALTH SERVICES, INC.
434 INDUSTRIAL LN.
BIRMINGHAM, AL 35211 US
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Contact TRACY WOOD COMAS
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Regulation Number 870.2700

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Classification Product Code NLF
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Date Received 07/09/2004
Decision Date 09/10/2004
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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