Clearance Summary
HBIDB - HUMAN BRIAN INDEX SOFTWARE received FDA 510(k) clearance under submission number K112077, sponsored by Corscience GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2012-03-09.
- Submission: K112077
- Applicant / Sponsor: Corscience GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2012-03-09
Classification & Regulation
This clearance is catalogued under FDA product code OLU and 21 CFR 882.1400, within the Neurology review panel as a Class II device.