BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    LuMon(TM) System

    K Number: K243765 · Decision Aug 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    5
    Review Days
    244

    Basic Information

    Device Name
    LuMon(TM) System
    K Number
    K243765
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1505
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sentec AG
    Date Received
    December 6, 2024
    Decision Date
    August 7, 2025
    Product Code
    QEB
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QEB Ventilatory Electrical Impedance Tomograph

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