Clearance Summary
EEG ELECTRODES MODEL 445 SERIES received FDA 510(k) clearance under submission number K982053, sponsored by Class A Ent.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1999-04-20.
- Submission: K982053
- Applicant / Sponsor: Class A Ent.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 1999-04-20
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.