Clearance Summary
HALO received FDA 510(k) clearance under submission number K200873, sponsored by Nico-Lab B.V.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-11-20.
- Submission: K200873
- Applicant / Sponsor: Nico-Lab B.V.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2080
- Decision date: 2020-11-20
Classification & Regulation
This clearance is catalogued under FDA product code QAS and 21 CFR 892.2080, within the Radiology review panel as a Class II device.