Clearance Summary
DENRICK SPEECH AID (DR-1) received FDA 510(k) clearance under submission number K931371, sponsored by Denrick Corp.. 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 1993-08-25.
- Submission: K931371
- Applicant / Sponsor: Denrick Corp.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3375
- Decision date: 1993-08-25
Classification & Regulation
This clearance is catalogued under FDA product code ESE and 21 CFR 874.3375, within the Ear, Nose, Throat review panel as a Class I device.