Clearance Summary
GMR40 received FDA 510(k) clearance under submission number K171085, sponsored by Neurologica Corporation, A Subsidiary OF. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2017-05-11.
- Submission: K171085
- Applicant / Sponsor: Neurologica Corporation, A Subsidiary OF
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2017-05-11
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.