Cleared Special

CoSense ETCO Monitor

K151107 · Capnia, Inc. · Anesthesiology
Jul 2015
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K151107 is an FDA 510(k) clearance for the CoSense ETCO Monitor, a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II — Special Controls, product code CCJ), submitted by Capnia, Inc. (Redwood City, US). The FDA issued a Cleared decision on July 22, 2015, 86 days after receiving the submission on April 27, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1430.

Submission Details

510(k) Number K151107 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2015
Decision Date July 22, 2015
Days to Decision 86 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCJ — Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1430