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FDA 510(k) Application Details - K221734
Device Classification Name
Analyzer, Gas, Oxygen, Gaseous-Phase
More FDA Info for this Device
510(K) Number
K221734
Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant
Maxtec, LLC
2305 South 1070 West
Salt Lake City, UT 84119 US
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Contact
Sidra Hankins
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Regulation Number
868.1720
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Classification Product Code
CCL
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More FDA Info for this Product Code
Date Received
06/15/2022
Decision Date
04/01/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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