Clearance Summary
MagVita TMS Therapy System received FDA 510(k) clearance under submission number K171481, sponsored by Tonica Elektronik A/S. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2017-06-16.
- Submission: K171481
- Applicant / Sponsor: Tonica Elektronik A/S
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5805
- Decision date: 2017-06-16
Classification & Regulation
This clearance is catalogued under FDA product code OBP and 21 CFR 882.5805, within the Neurology review panel as a Class II device.