510(k) K922757

SPS 1550 SINGLE NEEDLE PATIENT SYSTEM by Baxter Healthcare Corp — Product Code FKP

K922757 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "SPS 1550 SINGLE NEEDLE PATIENT SYSTEM". The FDA issued a decision of Substantially Equivalent on February 13, 1995. 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 at least 10 other 510(k) clearances on record.