Clearance Summary
CONVAID - SPEECH AID received FDA 510(k) clearance under submission number K841528, sponsored by Convaid , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1984-05-09.
- Submission: K841528
- Applicant / Sponsor: Convaid , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3710
- Decision date: 1984-05-09
Classification & Regulation
This clearance is catalogued under FDA product code ILQ and 21 CFR 890.3710, within the Physical Medicine review panel as a Class II device.