The following data is part of a premarket notification filed by Shenzhen Beacon Display Technology Co., Ltd. with the FDA for 5mp Color Lcd Monitors C53s+, C53sp+, 5mp Monochrome Lcd Monitors G53s+, G53sp+.
| Device ID | K200864 |
| 510k Number | K200864 |
| Device Name: | 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ |
| Classification | Display, Diagnostic Radiology |
| Applicant | Shenzhen Beacon Display Technology Co., Ltd. 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road Shenzhen, CN 518055 |
| Contact | Fu Ailing |
| Correspondent | Fu Ailing Shenzhen Beacon Display Technology Co., Ltd. 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road Shenzhen, CN 518055 |
| Product Code | PGY |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-01 |
| Decision Date | 2020-05-19 |