Clearance Summary
MICROEEG SYSTEM received FDA 510(k) clearance under submission number K112817, sponsored by Bio-Signal Group Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2012-06-19.
- Submission: K112817
- Applicant / Sponsor: Bio-Signal Group Corporation
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2012-06-19
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.