Clearance Summary
ELECTRO-PALATE received FDA 510(k) clearance under submission number K840892, sponsored by Cisko Systems. 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 1984-05-22.
- Submission: K840892
- Applicant / Sponsor: Cisko Systems
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3375
- Decision date: 1984-05-22
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.