BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    Hidroxa SE30

    K Number: K241267 · Decision Oct 17, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    164

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    Basic Information

    Device Name
    Hidroxa SE30
    K Number
    K241267
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5525
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hidroxa Medical AB
    Date Received
    May 6, 2024
    Decision Date
    October 17, 2024
    Product Code
    EGJ
    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
    EGJ Device, Iontophoresis, Other Uses

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