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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 K190848
Device Name JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
Applicant
Nanjing Jusha Display Technology Co., Ltd.
Suite A, 8/F, Bldg. 1, # 301, Hanzhongmen St.,
Nanjing,  CN 210036
Applicant Contact Zilong Liang
Correspondent
Nanjing Jusha Display Technology Co., Ltd.
Suite A, 8/F, Bldg. 1, # 301, Hanzhongmen St.,
Nanjing,  CN 210036
Correspondent Contact Zilong Liang
Regulation Number892.2050
Classification Product Code
PGY  
Date Received04/01/2019
Decision Date 05/14/2019
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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