Clearance Summary
101, 151, 161 PORTABLE AUDIOMETERS received FDA 510(k) clearance under submission number K802963, sponsored by Amplaid USA, Inc.. 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 1980-12-19.
- Submission: K802963
- Applicant / Sponsor: Amplaid USA, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 1980-12-19
Classification & Regulation
This clearance is catalogued under FDA product code EWO and 21 CFR 874.1050, within the Ear, Nose, Throat review panel as a Class II device.