BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    IRRIS (Infra-Red-Red Intubation System)

    K Number: K171411 · Decision Jan 12, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    1
    Review Days
    242

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    Basic Information

    Device Name
    IRRIS (Infra-Red-Red Intubation System)
    K Number
    K171411
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    A.R Guide IN Medical , Ltd.
    Date Received
    May 15, 2017
    Decision Date
    January 12, 2018
    Product Code
    BTR
    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
    BTR Tube, Tracheal (W/Wo Connector)

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