The following data is part of a premarket notification filed by Shenzhen Beacon Display Technology Co., Ltd. with the FDA for 2mp Color/monochrome Lcd Monitors C22s+, C22sp+/g22s+, G22sp+, G23s+, G23sp+.
Device ID | K201599 |
510k Number | K201599 |
Device Name: | 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ |
Classification | Display, Diagnostic Radiology |
Applicant | Shenzhen Beacon Display Technology Co., Ltd. 12F, Block Bl, NanshanZhiyuan, No.1001 Xueyuan Road Shenzhen, CN 518055 |
Contact | Fu Ailing |
Correspondent | Fu Ailing Shenzhen Beacon Display Technology Co., Ltd. 12F, Block Bl, NanshanZhiyuan, 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 | 2020-06-12 |
Decision Date | 2020-07-02 |