BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM

    K Number: K000081 · Decision Dec 19, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    206
    Applicant Total
    1
    Review Days
    343

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    Basic Information

    Device Name
    MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM
    K Number
    K000081
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5700
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Isotopes and Metals , Ltd.
    Date Received
    January 11, 2000
    Decision Date
    December 19, 2000
    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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