CoSense ETCO Monitor— 510(k) K253119

Substantially Equivalent

Capnia, Inc.

FDA 510(k) clearance K253119 for CoSense ETCO Monitor, Substantially Equivalent on 2026-05-29. 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: 2025-09-24
Decision date: 2026-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Capnia, Inc.

K151107 — CoSense ETCO Monitor2015-07-22
K130036 — COSENSE CO MONITOR2014-01-14
K121768 — COSENSE2012-10-31

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