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

    IONOTPHORETIC APPLICATOR

    K Number: K781700 · Decision Nov 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    14
    Review Days
    24

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    Basic Information

    Device Name
    IONOTPHORETIC APPLICATOR
    K Number
    K781700
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5525
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Mcghan Medical Corp.
    Date Received
    October 10, 1978
    Decision Date
    November 3, 1978
    Product Code
    KTB
    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
    KTB Device, Iontophoresis, Specific Uses

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