BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+

    K Number: K200864 · Decision May 19, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    134
    Applicant Total
    17
    Review Days
    48

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    Basic Information

    Device Name
    5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+
    K Number
    K200864
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Beacon Display Technology Co., Ltd.
    Date Received
    April 1, 2020
    Decision Date
    May 19, 2020
    Product Code
    PGY
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PGY Display, Diagnostic Radiology

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    Other Clearances by Shenzhen Beacon Display Technology Co., Ltd.

    K Number Device Name
    K252780 LCD Monitor (CL1902A, CL2103F)
    K253242 LCD Monitor (C1216W, C822W, C821W)
    K233119 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
    K243031 LCD Monitors C310S, G310S, C316S, G316S, C616W
    K240310 LCD Monitors C310S, G310S, C316S, G316S, C616W
    K233897 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
    K231026 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)
    K202374 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+
    K201211 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+
    K201599 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
    Search all 17 clearances from Shenzhen Beacon Display Technology Co., Ltd. →