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510(k) Data Aggregation

    K Number
    K171411
    Device Name
    IRRIS (Infra-Red-Red Intubation System)
    Date Cleared
    2018-01-12

    (242 days)

    Product Code
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    A.R Guide In Medical Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IRRIS is intended for use as an aid in the placement of an endotracheal tube (ETT) during intubation procedures performed with video-assisted devices.
    Device Description
    The IRRIS is designed for use as an aid in the placement of an endotracheal tube (ETT) during intubation procedures performed with video-assisted devices. The IRRIS is a non-invasive electronic illumination device. The device transmits light of a specific wavelength (near infra-red) to the underlying tissues. The light enables to illuminate the trachea of the patient, so it can be distinguished from other tissues while using video assisted devices (video-laryngoscopes).
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