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

    MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)

    K Number: K010548 · Decision Mar 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    246
    Registration Numbers
    246
    Same Product Code
    417
    Applicant Total
    8
    Review Days
    14

    Basic Information

    Device Name
    MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
    K Number
    K010548
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP
    Date Received
    February 26, 2001
    Decision Date
    March 12, 2001
    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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