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FDA 510(k) Application Details - K162343
Device Classification Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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510(K) Number
K162343
Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant
WESTMED, INC.
5580 S NOGALES HWY
TUCSON, AZ 85706 US
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Contact
DIANA UPP
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Regulation Number
868.1400
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Classification Product Code
CCK
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Date Received
08/22/2016
Decision Date
12/14/2016
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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