510(k) Report

Devices descending from K810925

2 later devices reach Naturalyte Bicarbonate Dialysate Concen. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070177Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 SeriesFresenius Medical Care North America2007035
+1K982813Naturalyte, Model # 08-4004-1Kaybath, Inc.19980—