Cleared Traditional

COSENSE CO MONITOR

K130036 · Capnia, Inc. · Anesthesiology
Jan 2014
Decision
372d
Days
Class 2
Risk

About This 510(k) Submission

K130036 is an FDA 510(k) clearance for the COSENSE CO MONITOR, 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 January 14, 2014, 372 days after receiving the submission on January 7, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1430.

Submission Details

510(k) Number K130036 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2013
Decision Date January 14, 2014
Days to Decision 372 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