510(k) K071909

PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R by Barkey GmbH & Co. KG — Product Code KOC

K071909 is an FDA 510(k) premarket notification submitted by Barkey GmbH & Co. KG for the device "PRISMACOMFORT, MODEL AUTOCONTROL 3XPT WITH AUTOLINE XPT 4R". The FDA issued a decision of Substantially Equivalent on October 18, 2007. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Barkey GmbH & Co. KG has at least 1 other 510(k) clearance on record.