Clearance Summary
COGNIVUE received FDA 510(k) clearance under submission number DEN130033, sponsored by Cerebral Assessment Systems, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-06-05.
- Submission: DEN130033
- Applicant / Sponsor: Cerebral Assessment Systems, Inc.
- Clearance pathway: Direct
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1470
- Decision date: 2015-06-05
Classification & Regulation
This clearance is catalogued under FDA product code PKQ and 21 CFR 882.1470, within the Neurology review panel as a Class II device.