510(k) K140113

O2 NASAL CANNULA WITH CO2 MONITORING by Flexicare Medical, Ltd. — Product Code CCK

K140113 is an FDA 510(k) premarket notification submitted by Flexicare Medical, Ltd. for the device "O2 NASAL CANNULA WITH CO2 MONITORING". The FDA issued a decision of Substantially Equivalent on March 6, 2014. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Flexicare Medical, Ltd. has at least 6 other 510(k) clearances on record.