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

    MMPC-4127F1

    K Number: K172922 · Decision Dec 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    60
    Review Days
    87

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    Basic Information

    Device Name
    MMPC-4127F1
    K Number
    K172922
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.3700
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Barco N.V.
    Date Received
    September 25, 2017
    Decision Date
    December 21, 2017
    Product Code
    PZZ
    Advisory Committee
    Pathology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PZZ Digital Pathology Display

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