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

    Demetra Analytics Toolkit

    K Number: K201408 · Decision Feb 18, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    60
    Review Days
    266

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    Basic Information

    Device Name
    Demetra Analytics Toolkit
    K Number
    K201408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Barco N.V.
    Date Received
    May 28, 2020
    Decision Date
    February 18, 2021
    Product Code
    PSN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PSN Light Based Imaging

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