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FDA 510(k) Application Details - K151107
Device Classification Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
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510(K) Number
K151107
Device Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Applicant
Capnia Inc
3 TWIN DOLPHIN DRIVE SUITE 160
REDWOOD CITY, CA 04065 US
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Contact
KRISTEN YEN
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Regulation Number
868.1430
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Classification Product Code
CCJ
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More FDA Info for this Product Code
Date Received
04/27/2015
Decision Date
07/22/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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