Clearance Summary
CEREBRALOGIK- AEEG received FDA 510(k) clearance under submission number K131789, sponsored by Mennen Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2013-12-27.
- Submission: K131789
- Applicant / Sponsor: Mennen Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2013-12-27
Classification & Regulation
This clearance is catalogued under FDA product code OMA and 21 CFR 882.1400, within the Neurology review panel as a Class II device.