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

    ENDOTRACHEAL TUBE HOLDER

    K Number: K942395 · Decision Jun 30, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    42

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    Basic Information

    Device Name
    ENDOTRACHEAL TUBE HOLDER
    K Number
    K942395
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5770
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    S.T.I. Medical Products Corp.
    Date Received
    May 19, 1994
    Decision Date
    June 30, 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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