BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR

    K Number: K934288 · Decision Jun 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    280

    Basic Information

    Device Name
    HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR
    K Number
    K934288
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5770
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    NEO-TECH, INC.
    Date Received
    September 2, 1993
    Decision Date
    June 9, 1994
    Product Code
    CBH
    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
    CBH Device, Fixation, Tracheal Tube

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