510(k) Report

Devices descending from K960097

12 later devices reach Chartr EP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083399Ics Chartr EP 200Gn Otometrics A/S2009111
+2K092373Ics Chartr EP 200Gn Otometrics200910—
+3K143670Ics Chartr EP 200 with VempGn Otometrics A/S20154—
+3K133012SentieroPath Medical GmbH201444
+4K220139QScreenPath Medical GmbH20220—
+4K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH202204
+4K163326SmartEPIntelligent Hearing Systems20171—
+4K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.20171—
+4K162037Eclipse with VEMPInteracoustics A/S20171—
+5K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.20240—
+5K193033GSI Audera ProGrason Stadler20200—
+5K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.20190—