510(k) K981681

PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) by Gambro Healthcare — Product Code KDI

K981681 is an FDA 510(k) premarket notification submitted by Gambro Healthcare for the device "PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)". The FDA issued a decision of Substantially Equivalent on August 11, 1998. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Gambro Healthcare has at least 10 other 510(k) clearances on record.