Clearance Summary
ITE HEARING AID PARKER/TECHNITONE, MODEL PA received FDA 510(k) clearance under submission number K884997, sponsored by Hearing Enhancement Center, 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 1989-03-29.
- Submission: K884997
- Applicant / Sponsor: Hearing Enhancement Center, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1989-03-29
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.