Clearance Summary
21.3INCH MONOCHROME LCD MONITOR received FDA 510(k) clearance under submission number K052942, sponsored by Nec-Mitsubishi Electric Visual Systems 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 2005-12-27.
- Submission: K052942
- Applicant / Sponsor: Nec-Mitsubishi Electric Visual Systems Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2005-12-27
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.