FDA 510(k) Application Details - K041127

Device Classification Name Oximeter, Reprocessed

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510(K) Number K041127
Device Name Oximeter, Reprocessed
Applicant STERILMED, INC.
11400 73RD AVE. NORTH
MINNEAPOLIS, MN 55369 US
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Contact BRUCE LESTER
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Regulation Number 870.2700

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Classification Product Code NLF
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Date Received 04/30/2004
Decision Date 09/23/2004
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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