Clearance Summary
Ponto Bone Anchored Hearing System, MONO Surgery Kit received FDA 510(k) clearance under submission number K203807, sponsored by Oticon Medical AB. The device was reviewed via the Special premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2021-03-03.
- Submission: K203807
- Applicant / Sponsor: Oticon Medical AB
- Clearance pathway: Special
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3302
- Decision date: 2021-03-03
Classification & Regulation
This clearance is catalogued under FDA product code MAH and 21 CFR 874.3302, within the Ear, Nose, Throat review panel as a Class II device.