Clearance Summary
INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER received FDA 510(k) clearance under submission number K994254, sponsored by International Distributors of Electronics For Medi. 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 2000-03-14.
- Submission: K994254
- Applicant / Sponsor: International Distributors of Electronics For Medi
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1090
- Decision date: 2000-03-14
Classification & Regulation
This clearance is catalogued under FDA product code ETY and 21 CFR 874.1090, within the Ear, Nose, Throat review panel as a Class II device.