510(k) Report

Devices descending from K021060

3 later devices reach Fresenius Icare Monitoring System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040074Oneview InterfaceNxstage Medical, Inc.20042—
+2K133547Nxstage System One with NxviewNxstage Medical, Inc.201412
+3K252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLC20260—