BEUDAMED
    Product Code: QEB FDA class 2 21 CFR 868.1505

    Ventilatory Electrical Impedance Tomograph

    Anesthesiology

    The Ventilatory Electrical Impedance Tomograph is a prescription, non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient's thorax, used to monitor regional lung ventilation distribution. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 868.1505 in the Anesthesiology specialty. The product code is QEB. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    6
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    4
    Years Active
    7

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    Basic Information

    Product Code
    QEB
    Device Class
    FDA class 2
    Regulation Number
    868.1505
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A ventilatory electrical impedance tomograph is a prescription non-invasive, non-radiological ventilatory device that provides an assessment of local impedance variation within a cross-section of a patient’s thorax.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 6 510(k) clearances via K numbers.

    K Number Device Name
    K250464 Enlight 2100 (TPL-E2103-0)
    K243765 LuMon(TM) System
    K222466 AirTom
    K222897 Enlight 2100
    K211135 Enlight 2100
    DEN170072 Enlight 1810

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.