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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 K230723
Device Name C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor
Applicant
Nanjing Jusha Display Technology Co., Ltd
8A, Block 1. Nanjing International Service Outsourcing
Mansion, No. 301 Hanzhongmen Street
Nanjing,  CN 210036
Applicant Contact Donny Lee
Correspondent
Nanjing Jusha Display Technology Co., Ltd
8A, Block 1. Nanjing International Service Outsourcing
Mansion, No. 301 Hanzhongmen Street
Nanjing,  CN 210036
Correspondent Contact Donny Lee
Regulation Number892.2050
Classification Product Code
PGY  
Date Received03/16/2023
Decision Date 05/18/2023
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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