510(k) K081447

FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO by Draeger Medical AG & Co. KG — Product Code BSZ

K081447 is an FDA 510(k) premarket notification submitted by Draeger Medical AG & Co. KG for the device "FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO". The FDA issued a decision of Substantially Equivalent on October 8, 2008. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Draeger Medical AG & Co. KG has at least 9 other 510(k) clearances on record.