510(k) Report

Devices descending from K002913

2 later devices reach Headband for Baha through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250215Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS)…Cochlear20250—
+1K171088Cochlear Baha SoundArcCochlear Americas20170—