FDA 510(k) Application Details - K231026

Device Classification Name

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510(K) Number K231026
Device Name 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models)
Applicant Shenzhen Beacon Display Technology Co.,Ltd.
15F, Building 6, Hengda Shishang Huigu(East), Fulong Road,
Dalang Subdistrict, Longhua
Shenzhen 518109 CN
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Contact Li Yafei
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Regulation Number

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Classification Product Code PGY
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Date Received 04/11/2023
Decision Date 08/18/2023
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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