Clearance Summary
GEM-STIM COMBO STIMULATOR received FDA 510(k) clearance under submission number K122948, sponsored by Gemore Technology Co, 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 2012-12-21.
- Submission: K122948
- Applicant / Sponsor: Gemore Technology Co, Ltd.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2012-12-21
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.