FDA 510(k) Application Details - K222019

Device Classification Name Oximeter, Reprocessed

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510(K) Number K222019
Device Name Oximeter, Reprocessed
Applicant Stryker Sustainability Solutions
1810 W Drake Drive
Tempe, AZ 85283 US
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Contact Michael Wong
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Regulation Number 870.2700

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Classification Product Code NLF
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Date Received 07/08/2022
Decision Date 12/04/2022
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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