Clearance Summary
MAGSTIM DOUBLE 70-2 COIL received FDA 510(k) clearance under submission number K130403, sponsored by The Magstim Company , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2013-08-23.
- Submission: K130403
- Applicant / Sponsor: The Magstim Company , Ltd.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1870
- Decision date: 2013-08-23
Classification & Regulation
This clearance is catalogued under FDA product code GWF and 21 CFR 882.1870, within the Neurology review panel as a Class II device.