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

    Mucosal Integrity Conductivity (MI) Test System

    K Number: DEN180067 · Decision Dec 23, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    371

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    Basic Information

    Device Name
    Mucosal Integrity Conductivity (MI) Test System
    K Number
    DEN180067
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    876.1450
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Diversatek Healthcare, Inc.
    Date Received
    December 17, 2018
    Decision Date
    December 23, 2019
    Product Code
    QIS
    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
    QIS Esophageal, Mucosal, Electrical Characterization

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