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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 K182291
Device Name 6MP Color LCD Monitor (C61W+)
Applicant
Shenzhen Beacon Display Technology Co., Ltd.
12f, Block B1, Nanshan Zhiyuan, #1001 Xueyuan Rd.
Shenzhen,  CN 518055
Applicant Contact Fu Ailing
Correspondent
Shenzhen Beacon Display Technology Co., Ltd.
12f, Block B1, Nanshan Zhiyuan, #1001 Xueyuan Rd.
Shenzhen,  CN 518055
Correspondent Contact Fu Ailing
Regulation Number892.2050
Classification Product Code
PGY  
Date Received08/23/2018
Decision Date 11/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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