510(k) K221118

CO2 Mainstream Sensor by Draegerwerk AG & CO Kgaa — Product Code CCK

K221118 is an FDA 510(k) premarket notification submitted by Draegerwerk AG & CO Kgaa for the device "CO2 Mainstream Sensor". The FDA issued a decision of Substantially Equivalent on April 5, 2023. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Draegerwerk AG & CO Kgaa has at least 7 other 510(k) clearances on record.