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    K Number
    DEN180067
    Device Name
    Mucosal Integrity Conductivity (MI) Test System
    Manufacturer
    Diversatek Healthcare Inc.
    Date Cleared
    2019-12-23

    (371 days)

    Product Code
    QIS
    Regulation Number
    876.1450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Diversatek Healthcare Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mucosal Integrity Conductivity Test System is indicated for use by gastroenterologists, surgeons, and medically trained personnel during an endoscopy to obtain a real time measurement of esophageal epithelial impedance. The device is not for use as a sole diagnostic screening tool.
    Device Description
    The Mucosal Integrity Conductivity (MI) Test System provides real-time measurements of alterations in esophageal evithelial integrity. The device is intended to aid in the evaluation of esophageal epithelial integrity by means of a balloon probe with direct electrical contact with the mucosal epithelium of the esophagus along with associated signal conditioning, hardware, and software for measuring and displaying information.
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