510(k) Report

Devices descending from K983352

7 later devices reach ILO2088 Enchocheck or ILO2088 Otocheck through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072033Otodynamics OtoportOtodynamics, Ltd.20076—
+2K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck…Otodynamics, Ltd.20152—
+2K122496Audx Pro Otoacoustic Emissions Measurement SystemBio-Logic Systems Corp.20120—
+2K112247A Baer with Abaer I/O FunctionNatus Medical Incorporated20121—
+2K111618Audx Otoacoustic Emissions Measurement System with Audx I/O FunctionNatus Medical Incorporated20111—
+3K234095OtoNova/OtoNova ProOtodynamics20240—
+3K240430Otoport ProOtodynamics, Ltd.20240—