COSENSE CO MONITOR— 510(k) K130036

Substantially Equivalent

Capnia, Inc.

FDA 510(k) clearance K130036 for COSENSE CO MONITOR, Substantially Equivalent on 2014-01-14. Applicant: Capnia, Inc.. Device class: 2.

Clearance details

Applicant: Capnia, Inc.
Product code: Code CCJ
Device class: Class 2
Regulation: 21 CFR 868.1430
Advisory panel: Anesthesiology
Date received: 2013-01-07
Decision date: 2014-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.