Cleared Traditional

CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),

K131410 · Southmedic, Inc. · Anesthesiology

Jan 2014

Decision

243d

Days

Class 2

Risk

About This 510(k) Submission

K131410 is an FDA 510(k) clearance for the CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Southmedic, Inc. (Barrie, Ontario, CA). The FDA issued a Cleared decision on January 13, 2014, 243 days after receiving the submission on May 15, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number	K131410 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2013
Decision Date	January 13, 2014
Days to Decision	243 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF