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

    OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR

    K Number: K881665 · Decision Aug 11, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    206
    Applicant Total
    7
    Review Days
    115

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    Basic Information

    Device Name
    OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR
    K Number
    K881665
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Omnitron Intl., Inc.
    Date Received
    April 18, 1988
    Decision Date
    August 11, 1988
    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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