Clearance Summary
MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION received FDA 510(k) clearance under submission number K091940, 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 2010-03-26.
- Submission: K091940
- Applicant / Sponsor: Tonica Elektronik A/S
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1870
- Decision date: 2010-03-26
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.