510(k) Report

Devices descending from K001058

6 later devices reach Audioscreener Oae + Abr through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K024205Audioscreener Oae+AbrEverest Biomedical Instruments Co.20035—
+2K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck…Otodynamics, Ltd.20152—
+2K031713Audiometer, Otoacoustic Emission, Auditory Branstem Response AccessViasys Healthcare, Inc.20031—
+3K234095OtoNova/OtoNova ProOtodynamics20240—
+3K240430Otoport ProOtodynamics, Ltd.20240—
+3K073384Smart Coupler, Model M015401Intelligent Hearing Systems20080—