FDA 510(k) Application Details - K231170

Device Classification Name

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510(K) Number K231170
Device Name C350/C350G LCD Monitor; M550/M550G LCD Monitor
Applicant Nanjing Jusha Display Technology Co., Ltd.
8A, Block 1. Nanjing International Service Outsourcing
Mansion, 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 04/25/2023
Decision Date 06/07/2023
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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