CoSense ETCO Monitor— 510(k) K151107

Substantially Equivalent

Capnia, Inc.

FDA 510(k) clearance K151107 for CoSense ETCO Monitor, Substantially Equivalent on 2015-07-22. 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: 2015-04-27
Decision date: 2015-07-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CCJ

K253119 — CoSense ETCO Monitor2026-05-29
K211918 — iCOquit® Smokerlyzer®2021-12-21
K201206 — Pivot Breath Sensor2021-06-30
K173238 — ToxCO2019-04-04
K171129 — CO Check Pro, CO Screen2018-03-02

More clearances from Capnia, Inc.

K130036 — COSENSE CO MONITOR2014-01-14
K121768 — COSENSE2012-10-31

Recalls naming K151107

K-number listed on FDA's recall record

Z-2198-2025 — Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide MonitorClass II·Ongoing·Capnia Inc·20250421

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151107.

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