BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇽 Mexico

    Mucosal Impedance Measurement System

    K Number: K233974 · Decision Sep 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    266

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    Basic Information

    Device Name
    Mucosal Impedance Measurement System
    K Number
    K233974
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1450
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alandra Medical Sapi DE CV
    Date Received
    December 15, 2023
    Decision Date
    September 6, 2024
    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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