Clearance Summary
STEREO AUDITORY TRAINER (MODEL PM228) received FDA 510(k) clearance under submission number K810031, sponsored by Hc Electronics. 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 1981-03-04.
- Submission: K810031
- Applicant / Sponsor: Hc Electronics
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3320
- Decision date: 1981-03-04
Classification & Regulation
This clearance is catalogued under FDA product code EPF and 21 CFR 874.3320, within the Ear, Nose, Throat review panel as a Class II device.