510(k) Report

Devices descending from K033645

3 later devices reach Otoflex 100 Tye 1012 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161707Madsen ZodiacGn Otometrics20160—
+1K061104Speechlink 100 Type 1053Gn Otometrics A/S20061—
+2K110286GN Otometrics Type 1053 FreefitGn Otometrics A/S20110—