510(k) Report

Devices descending from K010092

3 later devices reach Xltek Evoked Potential Headbox, Model Real Patient EP-8-RP (Proposed) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011794Xltek Led Goggles, Model Led-01Excel Tech., Ltd.20012—
+2K113785Adherent Visual Stimulator GogglesAnschel Technology, Inc.20121—
+3K200705Nurochek SystemCryptych Pty, Ltd.20200—