BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MEDION 6000

    K Number: K020476 · Decision May 3, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    72
    Applicant Total
    7
    Review Days
    80

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    Basic Information

    Device Name
    MEDION 6000
    K Number
    K020476
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5525
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Selectivemed Components, Inc.
    Date Received
    February 12, 2002
    Decision Date
    May 3, 2002
    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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    Other Clearances by Selectivemed Components, Inc.

    K Number Device Name
    K120922 GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
    K083756 GUARDIAN 150 ELECTRODE
    K031053 SELECTIVE MED COMPONENTS, INC. BUFFERED IONTOPHORESIS DRUG DELIVERY SYSTEM ELECTRODES, MODELS I20, I30, I40, I50, AND I7
    K993081 IO-DRIVE
    K946230 ENDURA REUSABLE TENS AND NMES ELECTRODES
    K945676 GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES