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

    ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT

    K Number: K914887 · Decision May 8, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    2
    Applicant Total
    43
    Review Days
    191

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    Basic Information

    Device Name
    ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT
    K Number
    K914887
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mallinckrodt Medical
    Date Received
    October 30, 1991
    Decision Date
    May 8, 1992
    Product Code
    FRQ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRQ Tube, Levine

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