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    FDA 510(k) FDA class 1 Substantially Equivalent 🇩🇪 Germany

    HANDHELD GAMMA FINDER (HGF)

    K Number: K013751 · Decision Feb 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    29
    Applicant Total
    1
    Review Days
    85

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    Basic Information

    Device Name
    HANDHELD GAMMA FINDER (HGF)
    K Number
    K013751
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1320
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Silicon Instruments Gmhb
    Date Received
    November 13, 2001
    Decision Date
    February 6, 2002
    Product Code
    IZD
    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
    IZD Probe, Uptake, Nuclear

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