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

    EZ-BLOCKER

    K Number: K121462 · Decision Sep 28, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    33
    Applicant Total
    1
    Review Days
    134

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    Basic Information

    Device Name
    EZ-BLOCKER
    K Number
    K121462
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5740
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ez-Blocker B.V.
    Date Received
    May 17, 2012
    Decision Date
    September 28, 2012
    Product Code
    CBI
    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
    CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CBI), ordered by most recent decision date.

    Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)

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