Clearance Summary
OMNI received FDA 510(k) clearance under submission number K811158, sponsored by Omni Hearing Systems. 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 1981-05-27.
- Submission: K811158
- Applicant / Sponsor: Omni Hearing Systems
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1981-05-27
Classification & Regulation
This clearance is catalogued under FDA product code ESD and 21 CFR 874.3300, within the Ear, Nose, Throat review panel as a Class I device.