Clearance Summary
35/CD CINECONVERTER received FDA 510(k) clearance under submission number K001841, sponsored by Tagarno A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2000-11-15.
- Submission: K001841
- Applicant / Sponsor: Tagarno A/S
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2030
- Decision date: 2000-11-15
Classification & Regulation
This clearance is catalogued under FDA product code LMA and 21 CFR 892.2030, within the Radiology review panel as a Class II device.