510(k) K944767

DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER by Fresenius USA, Inc. — Product Code FIP

K944767 is an FDA 510(k) premarket notification submitted by Fresenius USA, Inc. for the device "DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER". The FDA issued a decision of Substantially Equivalent on November 29, 1995. The device falls under product code FIP (Subsystem, Water Purification), a Class II device regulated under 21 CFR 876.5665. Fresenius USA, Inc. has at least 10 other 510(k) clearances on record.