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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 K212231
Device Name C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor
Applicant
Nanjing Jusha Display Technology Co., Ltd.
8A, Block 1. No. 301, Hanzhongmen Street
Nanjing,  CN 210036
Applicant Contact Donny Lee
Correspondent
Nanjing Jusha Display Technology Co., Ltd.
8A, Block 1. No. 301, Hanzhongmen Street
Nanjing,  CN 210036
Correspondent Contact Donny Lee
Regulation Number892.2050
Classification Product Code
PGY  
Date Received07/16/2021
Decision Date 03/25/2022
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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