FDA 510(k) Application Details - K945290

Device Classification Name Oximeter

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510(K) Number K945290
Device Name Oximeter
Applicant NONIN MEDICAL, INC.
2605 FERNBROOK LANE, NORTH
MINNEAPOLIS, MN 55447-4755 US
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Contact JERRY ZWEIGBAUM
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 10/31/1994
Decision Date 02/11/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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