Clearance Summary
SOLO-SLED received FDA 510(k) clearance under submission number K970090, sponsored by Solo-Sled, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-04-21.
- Submission: K970090
- Applicant / Sponsor: Solo-Sled, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1850
- Decision date: 1997-04-21
Classification & Regulation
This clearance is catalogued under FDA product code IXA and 21 CFR 892.1850, within the Radiology review panel as a Class II device.