FDA 510(k) Application Details - K230643

Device Classification Name

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510(K) Number K230643
Device Name CP620G LCD monitor, CP620 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 03/08/2023
Decision Date 05/01/2023
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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