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

    BRC SOFTWARE PRODUCT

    K Number: K050192 · Decision Oct 20, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    266

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    Basic Information

    Device Name
    BRC SOFTWARE PRODUCT
    K Number
    K050192
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brc Operations Pty Limited
    Date Received
    January 27, 2005
    Decision Date
    October 20, 2005
    Product Code
    OLU
    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
    OLU Normalizing Quantitative Electroencephalograph Software

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