510(k) Report

Devices descending from K050415

11 later devices reach Impedimed-Extracellular Fluid Analysis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080825Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400Impedimed Pty, Ltd.200810—
+2K143310MoisturemeterDDelfin Technologies, Ltd.20151—
+2K100811Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400ImpediMed Limited20117—
+3K220557MoistureMeterD Compact, LymphScannerDelfin Technologies, Ltd.20220—
+3K130338Impedimed - Bis Extra Cellular Fluid AnalysisImpediMed Limited20136—
+4K171186Cerebrotech CMS-5000Cerebrotech Medical Systems20172—
+4K172122SOZOImpediMed Limited20172—
+5K182967Visor SystemCerebrotech Medical Systems, Inc.20181—
+5K180126SOZOImpediMed Limited201811
+6K253840STEDI Scan DeviceStroke DX20260—
+6K230530SOZO ProImpediMed Limited20230—