Clearance Summary
FR MEDICAL X-RAY FILM received FDA 510(k) clearance under submission number K840806, sponsored by Fr Medical/Fr Chemicals. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1984-04-24.
- Submission: K840806
- Applicant / Sponsor: Fr Medical/Fr Chemicals
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1840
- Decision date: 1984-04-24
Classification & Regulation
This clearance is catalogued under FDA product code IWZ and 21 CFR 892.1840, within the Radiology review panel as a Class I device.