510(k) Report

Devices descending from K061791

4 later devices reach Focus VNG/Eng Type 1068 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151504ICS ImpulseGn Otometrics20153—
+2K242198ICS Dizcovery (1091)Natus Medical Denmark Aps20250—
+2K242726Synapsys VHITInventis S.R.L.20250—
+2K163270ISEN-Goggles with Data ViewerIsent Tech & Trading Company, Ltd.20170—