FDA 510(k) Application Details - K173807

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

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510(K) Number K173807
Device Name Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant Precision Medical Inc.
300 Held Drive
Northampton, PA 18067 US
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Contact James Parker
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Regulation Number 868.1720

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Classification Product Code CCL
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Date Received 12/15/2017
Decision Date 05/02/2018
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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