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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 K151238
Device Name JUSHA-M23C LCD Monitor
Applicant
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
301, HANZHONGMEN STREET, 8F BLOCK A, NO.1
MANSION, NANJING,  CN 210036
Applicant Contact Ma Jing
Correspondent
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
301, HANZHONGMEN STREET, 8F BLOCK A, NO.1
MANSION, NANJING,  CN 210036
Correspondent Contact Ma Jing
Regulation Number892.2050
Classification Product Code
PGY  
Date Received05/11/2015
Decision Date 06/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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