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

    R190/R191 LCD Monitor

    K Number: K183494 · Decision Apr 5, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    134
    Applicant Total
    26
    Review Days
    109

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    Basic Information

    Device Name
    R190/R191 LCD Monitor
    K Number
    K183494
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanjing Jusha Display Technology Co., Ltd.
    Date Received
    December 17, 2018
    Decision Date
    April 5, 2019
    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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