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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 K233897
Device Name 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
Applicant
Shenzhen Beacon Display Technology Co., Ltd.
15F, Building 6, Hengda Shishang Huigu (East)
Fulong Road, Dalang Subdistrict, Longhua
Shenzhen,  CN 518109
Applicant Contact Li Yafei
Correspondent
Shenzhen Beacon Display Technology Co., Ltd.
15F, Building 6, Hengda Shishang Huigu (East)
Fulong Road, Dalang Subdistrict, Longhua
Shenzhen,  CN 518109
Correspondent Contact Li Yafei
Regulation Number892.2050
Classification Product Code
PGY  
Date Received12/11/2023
Decision Date 02/06/2024
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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