Clearance Summary
ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID received FDA 510(k) clearance under submission number K922392, sponsored by A-1 Hearing Aid Lab. 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 1992-07-10.
- Submission: K922392
- Applicant / Sponsor: A-1 Hearing Aid Lab
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1992-07-10
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.