Clearance Summary
Prism received FDA 510(k) clearance under submission number K222101, sponsored by Graymatters Health , 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 2023-03-17.
- Submission: K222101
- Applicant / Sponsor: Graymatters Health , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 2023-03-17
Classification & Regulation
This clearance is catalogued under FDA product code HCC and 21 CFR 882.5050, within the Neurology review panel as a Class II device.