The following data is part of a premarket notification filed by Shenzhen Beacon Display Technology Co., Ltd. with the FDA for 3mp Color Lcd Monitors C32s+, C32sp+; 3mp Monochrome Lcd Monitors G32s+, G32sp+.
| Device ID | K201211 |
| 510k Number | K201211 |
| Device Name: | 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ |
| 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 | 2020-05-05 |
| Decision Date | 2020-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970027822418 | K201211 | 000 |
| 06970027820544 | K201211 | 000 |
| 06970027820421 | K201211 | 000 |
| 06970027820384 | K201211 | 000 |