Clearance Summary
encevis (2.1) received FDA 510(k) clearance under submission number K240993, sponsored by Ait Austrian Institute of Technology GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2024-09-27.
- Submission: K240993
- Applicant / Sponsor: Ait Austrian Institute of Technology GmbH
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2024-09-27
Classification & Regulation
This clearance is catalogued under FDA product code OMB and 21 CFR 882.1400, within the Neurology review panel as a Class II device.