3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+

Display, Diagnostic Radiology

Shenzhen Beacon Display Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Beacon Display Technology Co., Ltd. with the FDA for 3mp Color Lcd Monitors C32s+, C32sp+; 3mp Monochrome Lcd Monitors G32s+, G32sp+.

Pre-market Notification Details

Device IDK201211
510k NumberK201211
Device Name:3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+
ClassificationDisplay, Diagnostic Radiology
Applicant Shenzhen Beacon Display Technology Co., Ltd. 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road Shenzhen,  CN 518055
ContactFu Ailing
CorrespondentFu Ailing
Shenzhen Beacon Display Technology Co., Ltd. 12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road Shenzhen,  CN 518055
Product CodePGY  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-05
Decision Date2020-09-03

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