Clearance Summary
Cantab Mobile received FDA 510(k) clearance under submission number K161328, sponsored by Cambridge Cognition , Ltd., US Agent: Clementi Associates , 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 2017-01-13.
- Submission: K161328
- Applicant / Sponsor: Cambridge Cognition , Ltd., US Agent: Clementi Associates , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1470
- Decision date: 2017-01-13
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.