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

    OMNITRON GYN APPLICATOR SYSTEM

    K Number: K913908 · Decision Mar 6, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    206
    Applicant Total
    7
    Review Days
    189

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    Basic Information

    Device Name
    OMNITRON GYN APPLICATOR SYSTEM
    K Number
    K913908
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Omnitron Intl., Inc.
    Date Received
    August 30, 1991
    Decision Date
    March 6, 1992
    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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