FDA 510(k) Application Details - K112402

Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase

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510(K) Number K112402
Device Name Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant MAXTEC, LLC
6526 Cottonwood St # 300
Salt Lake City, UT 84107 US
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Contact TAMMY LAVERY
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Regulation Number 868.1720

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Classification Product Code CCL
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Date Received 08/22/2011
Decision Date 12/14/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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