Device Classification Name |
display, diagnostic radiology
|
510(k) Number |
K201211 |
Device Name |
3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ |
Applicant |
Shenzhen Beacon Display Technology Co., Ltd. |
12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road |
Shenzhen,
CN
518055
|
|
Applicant Contact |
Fu Ailing |
Correspondent |
Shenzhen Beacon Display Technology Co., Ltd. |
12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road |
Shenzhen,
CN
518055
|
|
Correspondent Contact |
Fu Ailing |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 05/05/2020 |
Decision Date | 09/03/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|