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

    TRANSQ3

    K Number: K001522 · Decision Oct 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    17
    Review Days
    155

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    Basic Information

    Device Name
    TRANSQ3
    K Number
    K001522
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5525
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Iomed, Inc.
    Date Received
    May 16, 2000
    Decision Date
    October 18, 2000
    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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