Clearance Summary
Apollo TMS Therapy System received FDA 510(k) clearance under submission number K180313, sponsored by Mag & More GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2018-05-04.
- Submission: K180313
- Applicant / Sponsor: Mag & More GmbH
- Clearance pathway: Abbreviated
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5805
- Decision date: 2018-05-04
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.