Clearance Summary
WAVE 2G, SOUL received FDA 510(k) clearance under submission number K130937, sponsored by Hansaton Akustik GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2014-01-03.
- Submission: K130937
- Applicant / Sponsor: Hansaton Akustik GmbH
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3400
- Decision date: 2014-01-03
Classification & Regulation
This clearance is catalogued under FDA product code KLW and 21 CFR 874.3400, within the Ear, Nose, Throat review panel as a Class II device.