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FDA 510(k) Application Details - K130036
Device Classification Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
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510(K) Number
K130036
Device Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Applicant
Capnia, Inc.
2445 FABER PLACE, STUITE 250
PALO ALTO, CA 94303 US
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Contact
Julie Blacklock
Other 510(k) Applications for this Contact
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
01/07/2013
Decision Date
01/14/2014
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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