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FDA 510(k) Application Details - K211138
Device Classification Name
Oximeter, Reprocessed
More FDA Info for this Device
510(K) Number
K211138
Device Name
Oximeter, Reprocessed
Applicant
Stryker Sustainability Solutions
1810 West Drake Drive
Tempe, AZ 85283 US
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Contact
Mia Brown
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Regulation Number
870.2700
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Classification Product Code
NLF
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More FDA Info for this Product Code
Date Received
04/16/2021
Decision Date
03/08/2022
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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