510(k) Report

Devices descending from K970674

4 later devices reach G.E.M. Water Systems, International through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030366Bicard Mixing SystemDialysis Systems, Inc.20040—
+1K023011Osmonics Solution Delivery SystemOsmonics Medical Systems20030—
+1K992793Sodium Bicarbonate Mixing/Delivery System, and the Concentrate Delivery SystemBetter Water, Inc.19991—
+2K051031Ameriwater Solution Mix and Distribution System for HemodialysisAmeriwater20060—