510(k) Report

Devices descending from K000097

5 later devices reach Gsi 2000 Middle Ear Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112733ER35 Ero-Scan Pro Hearing Test SystemEtymotic Research, Inc.20110—
+1K033645Otoflex 100 Tye 1012Gn Otometrics A/S20043—
+2K161707Madsen ZodiacGn Otometrics20160—
+2K061104Speechlink 100 Type 1053Gn Otometrics A/S20061—
+3K110286GN Otometrics Type 1053 FreefitGn Otometrics A/S20110—