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

    bite away neo

    K Number: K220514 · Decision Jun 23, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    259
    Registration Numbers
    259
    Same Product Code
    41
    Applicant Total
    2
    Review Days
    121

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    Basic Information

    Device Name
    bite away neo
    K Number
    K220514
    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
    February 22, 2022
    Decision Date
    June 23, 2022
    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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