Clearance Summary
PATPOS COMPACT received FDA 510(k) clearance under submission number K930295, sponsored by Cp Bio-Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1993-05-21.
- Submission: K930295
- Applicant / Sponsor: Cp Bio-Medical Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.5780
- Decision date: 1993-05-21
Classification & Regulation
This clearance is catalogued under FDA product code IWE and 21 CFR 892.5780, within the Radiology review panel as a Class I device.