Clearance Summary
Modius Sleep received FDA 510(k) clearance under submission number K230826, sponsored by Neurovalens , 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 2023-10-27.
- Submission: K230826
- Applicant / Sponsor: Neurovalens , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5800
- Decision date: 2023-10-27
Classification & Regulation
This clearance is catalogued under FDA product code QJQ and 21 CFR 882.5800, within the Neurology review panel as a Class II device.