The following data is part of a premarket notification filed by Shenzhen Beacon Display Technology Co., Ltd. with the FDA for 2mp Lcd Monitor (g22s+, G22sp+, C22s+, C22sp+).
Device ID | K172815 |
510k Number | K172815 |
Device Name: | 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) |
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 | 2017-09-18 |
Decision Date | 2017-10-27 |
Summary: | summary |