510(k) Report

Devices descending from K192211

2 later devices reach SoundBite Console, SoundBite Active Wire 18 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210839SoundBite Crossing System - Peripheral (14P)Soundbite Medical Solutions, Inc.20211—
+2K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc.20230—