510(k) Report

Devices descending from K080825

10 later devices reach Impedimed Extra Cellular Fluid Analysis, Model L-Dex U400 through their predicates, nearest generation first.

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