BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    INNOVO

    K Number: K192357 · Decision Jan 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    140

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    Basic Information

    Device Name
    INNOVO
    K Number
    K192357
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5330
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Atlantic Therapeutics, Ltd.
    Date Received
    August 29, 2019
    Decision Date
    January 16, 2020
    Product Code
    QAJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QAJ Cutaneous Electrode Stimulator For Urinary Incontinence

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