BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇧🇷 Brazil

    Enlight 1810

    K Number: DEN170072 · Decision Dec 20, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    447

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    Basic Information

    Device Name
    Enlight 1810
    K Number
    DEN170072
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    868.1505
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Applicant
    Timpel, Inc.
    Date Received
    September 29, 2017
    Decision Date
    December 20, 2018
    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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