Clearance Summary
THE COMMUNICATOR received FDA 510(k) clearance under submission number K821677, sponsored by Robert Swinney. , 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 1982-06-22.
- Submission: K821677
- Applicant / Sponsor: Robert Swinney. , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3710
- Decision date: 1982-06-22
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.