BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CONCEPT ENDOTRACHEAL TUBE

    K Number: K801213 · Decision May 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    83
    Review Days
    8

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    Basic Information

    Device Name
    CONCEPT ENDOTRACHEAL TUBE
    K Number
    K801213
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Concept, Inc.
    Date Received
    May 20, 1980
    Decision Date
    May 28, 1980
    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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