510(k) Report

Devices descending from K100811

7 later devices reach Impedimed - Extracellular Fluid Analyzer Model: L-Dex U400 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130338Impedimed - Bis Extra Cellular Fluid AnalysisImpediMed Limited20136—
+2K171186Cerebrotech CMS-5000Cerebrotech Medical Systems20172—
+2K172122SOZOImpediMed Limited20172—
+3K182967Visor SystemCerebrotech Medical Systems, Inc.20181—
+3K180126SOZOImpediMed Limited201811
+4K253840STEDI Scan DeviceStroke DX20260—
+4K230530SOZO ProImpediMed Limited20230—