Clearance Summary
VIDEO EEG OPTION MODIFICATION received FDA 510(k) clearance under submission number K933951, sponsored by Esaote Biomedica Spa. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1994-02-03.
- Submission: K933951
- Applicant / Sponsor: Esaote Biomedica Spa
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 1994-02-03
Classification & Regulation
This clearance is catalogued under FDA product code GWQ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.