Cleared Traditional

COSENSE

K121768 · Capnia, Inc. · Anesthesiology
Oct 2012
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K121768 is an FDA 510(k) clearance for the COSENSE, a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II — Special Controls, product code CCJ), submitted by Capnia, Inc. (Palo Alto, US). The FDA issued a Cleared decision on October 31, 2012, 138 days after receiving the submission on June 15, 2012. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1430.

Submission Details

510(k) Number K121768 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2012
Decision Date October 31, 2012
Days to Decision 138 days
Submission Type Traditional
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