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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
510(k) Number K121768
Device Name COSENSE
Applicant
Capnia, Inc.
2445 Faber Place, Stuite 250
Palo Alto,  CA  94303
Applicant Contact Julie Blacklock
Correspondent
Capnia, Inc.
2445 Faber Place, Stuite 250
Palo Alto,  CA  94303
Correspondent Contact Julie Blacklock
Regulation Number868.1430
Classification Product Code
CCJ  
Date Received06/15/2012
Decision Date 10/31/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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