510(k) K082758

PRISMAFLO II by Stihler Electronic GmbH — Product Code KOC

K082758 is an FDA 510(k) premarket notification submitted by Stihler Electronic GmbH for the device "PRISMAFLO II". The FDA issued a decision of Substantially Equivalent on December 19, 2008. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Stihler Electronic GmbH has at least 6 other 510(k) clearances on record.