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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 K183496
Device Name JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor
Applicant
Nanjing Jusha Display Technology Co., Ltd
Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St.
Nanjing,  CN 210036
Applicant Contact Zilong Liang
Correspondent
Nanjing Jusha Display Technology Co., Ltd
Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St.
Nanjing,  CN 210036
Correspondent Contact Zilong Liang
Regulation Number892.2050
Classification Product Code
PGY  
Date Received12/17/2018
Decision Date 04/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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