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    K Number
    K250464
    Device Name
    Enlight 2100 (TPL-E2103-0)
    Manufacturer
    Timpel S.A.
    Date Cleared
    2025-09-10

    (204 days)

    Product Code
    N/A
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K222897
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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 patients, from adults to infants, older than 29 days, 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 (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.

    AI/ML Overview

    N/A

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