Clearance Summary
Relivion received FDA 510(k) clearance under submission number K203419, sponsored by Neurolief , 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 2021-02-16.
- Submission: K203419
- Applicant / Sponsor: Neurolief , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5891
- Decision date: 2021-02-16
Classification & Regulation
This clearance is catalogued under FDA product code PCC and 21 CFR 882.5891, within the Neurology review panel as a Class II device.