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    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    CURIETRON 192 LOW DOSE RATE

    K Number: K881323 · Decision Jan 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    206
    Applicant Total
    2
    Review Days
    295

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    Basic Information

    Device Name
    CURIETRON 192 LOW DOSE RATE
    K Number
    K881323
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Compagnie Oris Industrie, S.A.
    Date Received
    March 28, 1988
    Decision Date
    January 17, 1989
    Product Code
    JAQ
    Advisory Committee
    Radiology
    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
    JAQ System, Applicator, Radionuclide, Remote-Controlled

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