BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*

    K Number: K864835 · Decision Feb 11, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    64

    Basic Information

    Device Name
    TAKANE AUTO ENEMATOR MODELS 1200R/G1300TR/G1300SR*
    K Number
    K864835
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5210
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    EISAI U.S.A., INC.
    Date Received
    December 9, 1986
    Decision Date
    February 11, 1987
    Product Code
    FCD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FCD Barium Enema Kit

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