Clearance Summary
5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ received FDA 510(k) clearance under submission number K200864, sponsored by Shenzhen Beacon Display Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-05-19.
- Submission: K200864
- Applicant / Sponsor: Shenzhen Beacon Display Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2020-05-19
Classification & Regulation
This clearance is catalogued under FDA product code PGY and 21 CFR 892.2050, within the Radiology review panel as a Class II device.