510(k) Report

Devices descending from K132957

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck…Otodynamics, Ltd.20152—
+2K234095OtoNova/OtoNova ProOtodynamics20240—
+2K240430Otoport ProOtodynamics, Ltd.20240—