510(k) K992894

MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 by Baxter Healthcare Corp — Product Code KDI

K992894 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576". The FDA issued a decision of Substantially Equivalent on Nov 24, 1999. 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. Baxter Healthcare Corp has 507 other 510(k) clearances on record.