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

    BRONCHOSCOPY TUBE W/ULTRA LOCUFF

    K Number: K833297 · Decision Dec 27, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    5
    Applicant Total
    29
    Review Days
    95

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    Basic Information

    Device Name
    BRONCHOSCOPY TUBE W/ULTRA LOCUFF
    K Number
    K833297
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5720
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Surgitek
    Date Received
    September 23, 1983
    Decision Date
    December 27, 1983
    Product Code
    BTS
    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
    BTS Tube, Bronchial (W/Wo Connector)

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