Clearance Summary
POLESTAR N-10 received FDA 510(k) clearance under submission number K002242, sponsored by Odin Technologies , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2000-09-20.
- Submission: K002242
- Applicant / Sponsor: Odin Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2000-09-20
Classification & Regulation
This clearance is catalogued under FDA product code LNH and 21 CFR 892.1000, within the Radiology review panel as a Class II device.