Clearance Summary
MagVenture TMS Atlas Neuro Navigation System received FDA 510(k) clearance under submission number K221544, sponsored by Tonica Elektronik A/S. 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: K221544
- Applicant / Sponsor: Tonica Elektronik A/S
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2023-03-17
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.