Clearance Summary
AUDIOTONE MODEL A97 received FDA 510(k) clearance under submission number K920092, sponsored by Miracle-Ear, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1992-01-28.
- Submission: K920092
- Applicant / Sponsor: Miracle-Ear, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 1992-01-28
Classification & Regulation
This clearance is catalogued under FDA product code LYY and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.