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

    IONOPHORELIC SWEAT STIM. CHLORIDE-

    K Number: K832059 · Decision Aug 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    475
    Review Days
    58

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    Basic Information

    Device Name
    IONOPHORELIC SWEAT STIM. CHLORIDE-
    K Number
    K832059
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5525
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Medtronic Vascular
    Date Received
    June 27, 1983
    Decision Date
    August 24, 1983
    Product Code
    KTB
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    CH
    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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