510(k) Report

Devices descending from K232089

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

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