Clearance Summary
MagVita TMS Therapy - w/MagPro R20 received FDA 510(k) clearance under submission number K170114, 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 2017-05-01.
- Submission: K170114
- Applicant / Sponsor: Tonica Elektronik A/S
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5805
- Decision date: 2017-05-01
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.