CoSense ETCO Monitor— 510(k) K253119
Substantially EquivalentCapnia, Inc.
FDA 510(k) clearance K253119 for CoSense ETCO Monitor, Substantially Equivalent on 2026-05-29. Applicant: Capnia, Inc.. Device class: 2.
Summary
Capnia's CoSense ETCO Monitor is filed under CCJ, gaseous-phase carbon monoxide gas analyzers. The record doesn't expand "ETCO".
Class II, 21 CFR 868.1430. Anesthesiology is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Capnia filed from Foster City, California. Review took 247 calendar days (September 24, 2025 to May 29, 2026).
Clearance details
- Applicant
- Capnia, Inc.
- Product code
- Product code CCJ
- Device class
- Class 2
- Regulation
- 21 CFR 868.1430
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foster City, CA, US
Recent devices under product code CCJ
view allMore clearances from Capnia, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.