Clearance Summary
INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER received FDA 510(k) clearance under submission number K982249, 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 1998-08-07.
- Submission: K982249
- 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 874.1050
- Decision date: 1998-08-07
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.