510(k) Report

Devices descending from K231204

2 later devices reach Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240155Cochlear Osia SystemCochlear Americas20241—
+2K260902Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3…Cochlear Americas20260—