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    FDA 510(k) FDA class 2 Substantially Equivalent 🇧🇷 Brazil

    Enlight 2100 (TPL-E2103-0)

    K Number: K250464 · Decision Sep 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    3
    Review Days
    204

    Basic Information

    Device Name
    Enlight 2100 (TPL-E2103-0)
    K Number
    K250464
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1505
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Timpel S.A.
    Date Received
    February 18, 2025
    Decision Date
    September 10, 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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    Other Clearances by Timpel S.A.

    K Number Device Name
    K222897 Enlight 2100
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