FDA 510(k) Application Details - K012600

Device Classification Name Oximeter, Reprocessed

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510(K) Number K012600
Device Name Oximeter, Reprocessed
Applicant CLEAR MEDICAL, INC.
1776 136TH PL. NE
BELLEVUE, WA 98005 US
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Contact RICHARD RADFORD
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Regulation Number 870.2700

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Classification Product Code NLF
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Date Received 08/13/2001
Decision Date 07/03/2002
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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