BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    bite away two

    K Number: K250047 · Decision Sep 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    259
    Registration Numbers
    259
    Same Product Code
    41
    Applicant Total
    2
    Review Days
    245

    Basic Information

    Device Name
    bite away two
    K Number
    K250047
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5740
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    mibeTec GmbH
    Date Received
    January 10, 2025
    Decision Date
    September 12, 2025
    Product Code
    IRT
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IRT Pad, Heating, Powered

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