Clearance Summary
SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS received FDA 510(k) clearance under submission number K802687, sponsored by Intelligent Software Systems, Inc.. 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 1981-02-04.
- Submission: K802687
- Applicant / Sponsor: Intelligent Software Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3710
- Decision date: 1981-02-04
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.