510(k) K100941

INFINITY MCABLE - MAINSTREAM CO2 by Draeger Medical AG & Co. KG — Product Code CCK

K100941 is an FDA 510(k) premarket notification submitted by Draeger Medical AG & Co. KG for the device "INFINITY MCABLE - MAINSTREAM CO2". The FDA issued a decision of Substantially Equivalent on April 23, 2010. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Draeger Medical AG & Co. KG has at least 9 other 510(k) clearances on record.