510(k) Report

Devices descending from K203473

3 later devices reach SOZO through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232089SOZO ProImpediMed Limited20232—
+2K260224MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)ImpediMed Limited20260—
+2K253224MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)ImpediMed Limited20260—