510(k) K072002

FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 by Draeger Medical AG & Co. KG — Product Code CAH

K072002 is an FDA 510(k) premarket notification submitted by Draeger Medical AG & Co. KG for the device "FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55". The FDA issued a decision of Substantially Equivalent on January 31, 2008. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Draeger Medical AG & Co. KG has at least 9 other 510(k) clearances on record.