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

    ELECTROAPPLICATOR MODEL C-1

    K Number: K790205 · Decision Mar 19, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    1
    Review Days
    47

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    Basic Information

    Device Name
    ELECTROAPPLICATOR MODEL C-1
    K Number
    K790205
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5525
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Mcg, Inc.
    Date Received
    January 31, 1979
    Decision Date
    March 19, 1979
    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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