Clearance Summary
CHILI VIDEO, CHILI VIDEOPRO received FDA 510(k) clearance under submission number K000411, sponsored by Steinbeis-Transferzentrum Medizinische Informatik. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2000-04-14.
- Submission: K000411
- Applicant / Sponsor: Steinbeis-Transferzentrum Medizinische Informatik
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2030
- Decision date: 2000-04-14
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.