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    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇪 Belgium

    MDNG-3220 (Nio 3MP LED)

    K Number: K150821 · Decision Apr 10, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    134
    Applicant Total
    1
    Review Days
    14

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    Basic Information

    Device Name
    MDNG-3220 (Nio 3MP LED)
    K Number
    K150821
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Barco
    Date Received
    March 27, 2015
    Decision Date
    April 10, 2015
    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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