Clearance Summary
WINNER CM4 COMBINATION UNIT received FDA 510(k) clearance under submission number K012848, sponsored by Rich-Mar Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-10-25.
- Submission: K012848
- Applicant / Sponsor: Rich-Mar Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2001-10-25
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.