510(k) Report

Devices descending from K994149

21 later devices reach Modification to Bio-Logic Evoked Potential for Abaer/ Navigator Pro. through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030907Stacked Abr for Navigator ProBio-Logic Systems Corp.20031—
+1K031009Modification to Bio-Logic Evoked Potential (EP) SystemBio-Logic Systems Corp.20031—
+1K021895Bio-Logic Master Evoked Response SystemBio-Logic Systems Corp.200213—
+1K021215Bio-Logic Abaer CubBio-Logic Systems Corp.20025—
+2K083371Navigator Pro with Aep Software (Biomark, Enog, Champ)Natus Medical, Inc.20090—
+2K073626Bio-Logic Master II Evoked Response SystemBio-Logic Systems Corp.20081—
+2K070696Interacoustics Assr, Eclipse System (Cabinet Name)Interacoustics A/S20076—
+2K031051Smartep-Assr, Model M811007Intelligent Hearing Systems20043—
+2K021801Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsBio-Logic Systems Corp.20024—
+3K141524Neuro-AudioTeleemg, LLC USA20150—
+3K133012SentieroPath Medical GmbH201444
+3K112247A Baer with Abaer I/O FunctionNatus Medical Incorporated20121—
+3K111618Audx Otoacoustic Emissions Measurement System with Audx I/O FunctionNatus Medical Incorporated20111—
+3K090579Smartscreener-PLUS2Intelligent Hearing Systems20090—
+3K061443Smart Usblite, Model M011120Intelligent Hearing Systems20061—
+4K220139QScreenPath Medical GmbH20220—
+4K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH202204
+4K193033GSI Audera ProGrason Stadler20200—
+4K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.20171—
+4K122496Audx Pro Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp.20120—
+5K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.20190—