510(k) K832547

ULTRAFILTRATION CONTROLLER by Extracorporeal Medical Specialities, Inc. — Product Code KDI

K832547 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "ULTRAFILTRATION CONTROLLER". The FDA issued a decision of Substantially Equivalent on January 3, 1984. 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. Extracorporeal Medical Specialities, Inc. has at least 10 other 510(k) clearances on record.