FDA 510(k) Application Details - K212231

Device Classification Name

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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 210036 CN
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Contact Donny Lee
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Regulation Number

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Classification Product Code PGY
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Date Received 07/16/2021
Decision Date 03/25/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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