Clearance Summary
KLS Martin Individual Patient Solutions (IPS) Planning System received FDA 510(k) clearance under submission number K201052, sponsored by KLS-Martin L.P.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2020-08-31.
- Submission: K201052
- Applicant / Sponsor: KLS-Martin L.P.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4310
- Decision date: 2020-08-31
Classification & Regulation
This clearance is catalogued under FDA product code PPT and 21 CFR 882.4310, within the Neurology review panel as a Class II device.