BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    MD210C3 21.3 Diagnostic Imaging LCD Monitor

    K Number: K142951 · Decision Dec 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    134
    Applicant Total
    15
    Review Days
    61

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    Basic Information

    Device Name
    MD210C3 21.3 Diagnostic Imaging LCD Monitor
    K Number
    K142951
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nec Display Solutions , Ltd.
    Date Received
    October 10, 2014
    Decision Date
    December 10, 2014
    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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