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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 Number892.2050
Classification Product Code
PGY  
Date Received05/05/2020
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
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