510(k) Report

Devices descending from K883111

3 later devices reach Heomdialysis Single Patient System (SPS) Model 650 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992894Meridian Hemodialysis Machine, Model 5M5576Baxter Healthcare Corp199925
+2K053539Meridian Hemodialysis Machine, Model 5M5576Baxter Healthcare Corporation20060—
+2K013562Aurora System 1000 Series Home Self-Care Single Patient Delivery System; Models- Sys…Baxter Healthcare Corp200202