510(k) Report

Devices descending from K934658

20 later devices reach Gsi 60 Dpoae System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031713Audiometer, Otoacoustic Emission, Auditory Branstem Response AccessViasys Healthcare, Inc.20031—
+1K974237Gsi 70 Audiopath ScreenerGrason-Stadler, Inc.199818—
+1K970324Gsi SA60 Dpoae SystemGrason-Stadler, Inc.19970—
+2K073384Smart Coupler, Model M015401Intelligent Hearing Systems20080—
+2K982642Echo-ScreenFischer-Zoth Audiologic Systems, Inc.199815—
+3K013977Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc.200214—
+4K141446Echo-Screen Iii Pro Hearing Screener with Barcode Scanner, Echo-Screen Iii Pro Hearing…Natus Medical Incorporated20140—
+4K132957Madsen Accuscreen Type 1077Gn Otometrics20143—
+4K131141EarprobePath Medical GmbH20130—
+4K122067Type 1077 AccuscreenGn Otometrics20129—
+4K100661EarprobePath Medical GmbH201001
+4K061744Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp.20065—
+5K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck…Otodynamics, Ltd.20152—
+5K133012SentieroPath Medical GmbH201444
+6K234095OtoNova/OtoNova ProOtodynamics20240—
+6K240430Otoport ProOtodynamics, Ltd.20240—
+6K220139QScreenPath Medical GmbH20220—
+6K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH202204
+6K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.20171—
+7K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.20190—