Clearance Summary
MagVenture TMS Therapy for treatment of OCD, MagVenture TMS Therapy system received FDA 510(k) clearance under submission number K193006, 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 2020-08-09.
- Submission: K193006
- Applicant / Sponsor: Tonica Elektronik A/S
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5802
- Decision date: 2020-08-09
Classification & Regulation
This clearance is catalogued under FDA product code QCI and 21 CFR 882.5802, within the Neurology review panel as a Class II device.