510(k) Report

Devices descending from K823115

1 later device reach Naturalyte Bicarbonate Dialysate 4400 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070177Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 SeriesFresenius Medical Care North America2007035