Clearance Summary
TECH. CLARATRON & INDUSTRIAL AMPLIFIER received FDA 510(k) clearance under submission number K823244, sponsored by Longview Hearing Aid Center. 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 1983-01-17.
- Submission: K823244
- Applicant / Sponsor: Longview Hearing Aid Center
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1983-01-17
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.