Clearance Summary
POLESTAR N-20 received FDA 510(k) clearance under submission number K032541, sponsored by Odin Medical Technologies , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-09-12.
- Submission: K032541
- Applicant / Sponsor: Odin Medical Technologies , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2003-09-12
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.