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

    MEROCEL(R) LASER-GUARD(TM)

    K Number: K910463 · Decision Apr 6, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    10
    Review Days
    437

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    Basic Information

    Device Name
    MEROCEL(R) LASER-GUARD(TM)
    K Number
    K910463
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Merocel Corp.
    Date Received
    January 25, 1991
    Decision Date
    April 6, 1992
    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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