Clearance Summary
Jabra Enhance Plus received FDA 510(k) clearance under submission number K213424, sponsored by GN Hearing A/S. 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 2022-01-19.
- Submission: K213424
- Applicant / Sponsor: GN Hearing A/S
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3325
- Decision date: 2022-01-19
Classification & Regulation
This clearance is catalogued under FDA product code QDD and 21 CFR 874.3325, within the Ear, Nose, Throat review panel as a Class II device.