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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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More FDA Info for this Product Code
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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