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510(k) Data Aggregation

    K Number
    K222897
    Device Name
    Enlight 2100
    Manufacturer
    Timpel S.A.
    Date Cleared
    2023-03-07

    (165 days)

    Product Code
    QEB, BZK
    Regulation Number
    868.1505
    Why did this record match?
    Applicant Name (Manufacturer) :

    Timpel S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENLIGHT 2100 is a non-invasive, radiation free medical device that provides information from impedance variation from a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's thorax. ENLIGHT 2100 also provides respiratory parameters based on spirometric monitoring. It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 - 134 cm. ENLIGHT 2100 does not measure regional ventilation of the lungs
    Device Description
    ENLIGHT 2100 is a Ventilatory electrical impedance tomograph that uses several electrodes (usually between 16 and 32) placed around the patient's thorax to assess regional impedance variation in a lung slice (tomography). It provides a relative measurement, so it only provides information on variations in local impedance. ENLIGHT 2100 estimates Local Impedance Variation, occurring in a cross section of the thorax during a respiratory cycle, and which are linearly related to Variations in Regional Air Content within the lung.
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    K Number
    K211135
    Device Name
    Enlight 2100
    Manufacturer
    Timpel S.A.
    Date Cleared
    2022-01-06

    (265 days)

    Product Code
    QEB, OEB
    Regulation Number
    868.1505
    Why did this record match?
    Applicant Name (Manufacturer) :

    Timpel S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ENLIGHT 2100 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient's thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user's assessment of variations in regional air content within a cross section of a patient's lungs. It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 - 134cm. ENLIGHT 2100 does not measure regional ventilation of the lungs.
    Device Description
    ENLIGHT 2100 is a Ventilatory electrical impedance tomograph that uses several electrodes (usually between 16 and 32) placed around the patient's thorax to assess regional impedance variation in a lung slice (tomography). It provides a relative measurement, so it only provides information on variations in local impedance. ENLIGHT 2100 estimates Local Impedance Variation, occurring in a cross section of the thorax during a respiratory cycles, and which are linearly related to Variations in Regional Air Content within the lung.
    Ask a Question

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