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

    KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP

    K Number: K902193 · Decision Mar 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    2
    Review Days
    303

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    Basic Information

    Device Name
    KEVTEK LASER-STOP ENDOTRACHEAL TUBE LASER-STOP
    K Number
    K902193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Kevtek Medical Products, Inc.
    Date Received
    May 16, 1990
    Decision Date
    March 15, 1991
    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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    Other Clearances by Kevtek Medical Products, Inc.

    K Number Device Name
    K902000 KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD