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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K151854
Device Name 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display
Applicant
D-View Display Technology Co., Ltd.
3f, Bldg. 4, #12# Kechuang 13th St., Bda Area
Bei Jing,  CN 100176
Applicant Contact JIANFEI SUN
Correspondent
D-View Display Technology Co., Ltd.
3f, Bldg. 4, #12# Kechuang 13th St., Bda Area
Bei Jing,  CN 100176
Correspondent Contact JIANFEI SUN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/07/2015
Decision Date 07/28/2015
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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