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

    YAG LASER 8000 GASTROINTESTINAL BLEE

    K Number: K840144 · Decision May 18, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    5
    Review Days
    126

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    Basic Information

    Device Name
    YAG LASER 8000 GASTROINTESTINAL BLEE
    K Number
    K840144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Cooper Medical Corp.
    Date Received
    January 13, 1984
    Decision Date
    May 18, 1984
    Product Code
    FCG
    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
    FCG Biopsy Needle

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