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

    RH-950

    K Number: K033192 · Decision Dec 22, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    17
    Review Days
    81

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    Basic Information

    Device Name
    RH-950
    K Number
    K033192
    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
    October 2, 2003
    Decision Date
    December 22, 2003
    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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