Clearance Summary
GRINDCARE MEASURE received FDA 510(k) clearance under submission number K113677, sponsored by Medotech A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2012-04-05.
- Submission: K113677
- Applicant / Sponsor: Medotech A/S
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.1375
- Decision date: 2012-04-05
Classification & Regulation
This clearance is catalogued under FDA product code KZM and 21 CFR 890.1375, within the Physical Medicine review panel as a Class II device.