FDA 510(k) Application Details - K222121

Device Classification Name

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510(K) Number K222121
Device Name C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor
Applicant Nanjing Jusha Display Technology Co., Ltd.
8A, Block 1, 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 07/18/2022
Decision Date 09/19/2022
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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