Clearance Summary
INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER received FDA 510(k) clearance under submission number K990652, sponsored by Idem (Int'L Dist. of Electronics For Medicine). 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 1999-05-17.
- Submission: K990652
- Applicant / Sponsor: Idem (Int'L Dist. of Electronics For Medicine)
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1090
- Decision date: 1999-05-17
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.