Clearance Summary
Neu Platform received FDA 510(k) clearance under submission number K250153, sponsored by Neuhealth Digital , 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 2025-04-25.
- Submission: K250153
- Applicant / Sponsor: Neuhealth Digital , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1950
- Decision date: 2025-04-25
Classification & Regulation
This clearance is catalogued under FDA product code GYD and 21 CFR 882.1950, within the Neurology review panel as a Class II device.