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

    INFINITY EXPLORER

    K Number: K013515 · Decision Jan 10, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    77
    Applicant Total
    781
    Review Days
    80

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    Basic Information

    Device Name
    INFINITY EXPLORER
    K Number
    K013515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Solutions USA, Inc.
    Date Received
    October 22, 2001
    Decision Date
    January 10, 2002
    Product Code
    DXJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXJ Display, Cathode-Ray Tube, Medical

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