FDA 510(k) Application Details - K230723

Device Classification Name

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510(K) Number K230723
Device Name C510G/JUSHA-C510G/C510/JUSHA- C510 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 03/16/2023
Decision Date 05/18/2023
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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