Clearance Summary
GRINDCARE received FDA 510(k) clearance under submission number K092675, sponsored by Medotech 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 2010-03-03.
- Submission: K092675
- Applicant / Sponsor: Medotech A/S
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5050
- Decision date: 2010-03-03
Classification & Regulation
This clearance is catalogued under FDA product code HCC and 21 CFR 882.5050, within the Neurology review panel as a Class II device.