Clearance Summary
GEODESIC EEG MOBILE 100 (GEM 100) received FDA 510(k) clearance under submission number K112353, sponsored by Electrical Geodesics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2012-02-17.
- Submission: K112353
- Applicant / Sponsor: Electrical Geodesics, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2012-02-17
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.