510(k) Report

Devices descending from K031051

3 later devices reach Smartep-Assr, Model M811007 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090579Smartscreener-PLUS2Intelligent Hearing Systems20090—
+1K061443Smart Usblite, Model M011120Intelligent Hearing Systems20061—
+2K193033GSI Audera ProGrason Stadler20200—