510(k) Report

Devices descending from K122067

9 later devices reach Type 1077 Accuscreen through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133012SentieroPath Medical GmbH201444
+1K132957Madsen Accuscreen Type 1077Gn Otometrics20143—
+2K220139QScreenPath Medical GmbH20220—
+2K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH202204
+2K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.20171—
+2K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck…Otodynamics, Ltd.20152—
+3K234095OtoNova/OtoNova ProOtodynamics20240—
+3K240430Otoport ProOtodynamics, Ltd.20240—
+3K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.20190—