510(k) K213518

CARESCAPE CO2 Microstream parameter by Covidien, LLC — Product Code CCK

K213518 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "CARESCAPE CO2 Microstream parameter". The FDA issued a decision of Substantially Equivalent on April 12, 2022. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Covidien, LLC has at least 10 other 510(k) clearances on record.