Clearance Summary
ITE HEARING AID, EAR-TRONICS MODELS: M1-M23 received FDA 510(k) clearance under submission number K881299, sponsored by Ear-Tronics, Inc.. 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 1988-08-05.
- Submission: K881299
- Applicant / Sponsor: Ear-Tronics, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1988-08-05
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.