510(k) K131410

CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE), by Southmedic, Inc. — Product Code CCK

K131410 is an FDA 510(k) premarket notification submitted by Southmedic, Inc. for the device "CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),". The FDA issued a decision of Substantially Equivalent on January 13, 2014. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Southmedic, Inc. has at least 9 other 510(k) clearances on record.