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

    SURGITEK ULTRA-LO CUFF

    K Number: K830504 · Decision Apr 12, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    2
    Review Days
    55

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    Basic Information

    Device Name
    SURGITEK ULTRA-LO CUFF
    K Number
    K830504
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Mec/Surgitek Products
    Date Received
    February 16, 1983
    Decision Date
    April 12, 1983
    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 Mec/Surgitek Products

    K Number Device Name
    K831446 SURGITEK NEPHROSTENT KIT