Clearance Summary
SoundBite Console, SoundBite Active Wire 18 received FDA 510(k) clearance under submission number K192211, sponsored by Soundbite Medical Solution, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-01-17.
- Submission: K192211
- Applicant / Sponsor: Soundbite Medical Solution, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2020-01-17
Classification & Regulation
This clearance is catalogued under FDA product code PDU and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.