510(k) Report

Devices descending from K083597

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203251SOLOPASS SystemIntravent Medical Partners, LP20211—
+1K112469General Prupose Localizers and Adapters-New Accessories for Sonowand SystemSonowand AS20122—
+2K251317SOLOPASS 2.0 SystemIntravent Medical Partners20250—