510(k) K883111

HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650 by Baxter Healthcare Corp — Product Code FKP

K883111 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650". The FDA issued a decision of Substantially Equivalent on Feb 8, 1989. The device falls under product code FKP (System, Dialysate Delivery, Single Patient), a Class II device regulated under 21 CFR 876.5820. Baxter Healthcare Corp has 507 other 510(k) clearances on record.