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

    ENDOMAP

    K Number: K014113 · Decision Jun 14, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    781
    Review Days
    182

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    Basic Information

    Device Name
    ENDOMAP
    K Number
    K014113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Solutions USA, Inc.
    Date Received
    December 14, 2001
    Decision Date
    June 14, 2002
    Product Code
    HAW
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HAW Neurological Stereotaxic Instrument

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