510(k) Report

Devices descending from K130338

6 later devices reach Impedimed - Bis Extra Cellular Fluid Analysis through their predicates, nearest generation first.

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