FDA 510(k) Application Details - K192900

Device Classification Name Oximeter

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510(K) Number K192900
Device Name Oximeter
Applicant Nonin Medical, Inc.
13700 1st Avenue North
Plymouth, MN 55441 US
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Contact Kim E Aves
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 10/15/2019
Decision Date 06/29/2020
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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