510(k) K213911

Microstream CO2 NanoPod by Covidien, LLC — Product Code CCK

K213911 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "Microstream CO2 NanoPod". The FDA issued a decision of Substantially Equivalent on July 29, 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.