510(k) Report

Devices descending from K013977

14 later devices reach Echo-Screen T, TA, TD, Tda, TC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141446Echo-Screen Iii Pro Hearing Screener with Barcode Scanner, Echo-Screen Iii Pro Hearing…Natus Medical Incorporated20140—
+1K132957Madsen Accuscreen Type 1077Gn Otometrics20143—
+1K131141EarprobePath Medical GmbH20130—
+1K122067Type 1077 AccuscreenGn Otometrics20129—
+1K100661EarprobePath Medical GmbH201001
+1K061744Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp.20065—
+2K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck…Otodynamics, Ltd.20152—
+2K133012SentieroPath Medical GmbH201444
+3K234095OtoNova/OtoNova ProOtodynamics20240—
+3K240430Otoport ProOtodynamics, Ltd.20240—
+3K220139QScreenPath Medical GmbH20220—
+3K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH202204
+3K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.20171—
+4K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.20190—