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

    TUMORLOCALIZER MRI

    K Number: K962615 · Decision Mar 19, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    1
    Applicant Total
    57
    Review Days
    624

    Basic Information

    Device Name
    TUMORLOCALIZER MRI
    K Number
    K962615
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ferguson Medical
    Date Received
    July 3, 1996
    Decision Date
    March 19, 1998
    Product Code
    MIG
    Advisory Committee
    Unknown
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MIG Strip, Test Isoniazid

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