Clearance Summary
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T received FDA 510(k) clearance under submission number K233119, sponsored by Shenzhen Beacon Display Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 2024-12-28.
- Submission: K233119
- Applicant / Sponsor: Shenzhen Beacon Display Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class II
- Regulation citation: 21 CFR 864.3700
- Decision date: 2024-12-28
Classification & Regulation
This clearance is catalogued under FDA product code PZZ and 21 CFR 864.3700, within the Pathology review panel as a Class II device.