The following data is part of a premarket notification filed by Shenzhen Beacon Display Technology Co., Ltd. with the FDA for 6mp Color Lcd Monitor (c61w+).
| Device ID | K182291 |
| 510k Number | K182291 |
| Device Name: | 6MP Color LCD Monitor (C61W+) |
| 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 | 2018-08-23 |
| Decision Date | 2018-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970027823613 | K182291 | 000 |