510(k) Report

Devices descending from K142503

10 later devices reach Imed-Z Fluid Status Monitor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250634BCM2-Body Composition MonitorFresenius Medical Care Renal Therapies Group, LLC20250—
+1K243727Re:BalansMode Sensors AS20250—
+1K172507SOZOImpediMed Limited20177—
+2K193410SOZO Body Fluid AnalyzerImpediMed Limited20204—
+2K190529SOZOImpediMed Limited20191—
+3K230531SOZO ProImpediMed Limited20230—
+3K203473SOZOImpediMed Limited20213—
+4K232089SOZO ProImpediMed Limited20232—
+5K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed Limited20260—
+5K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)ImpediMed Limited20260—