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

    ZOOM-100DC

    K Number: K082886 · Decision Aug 10, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    53
    Applicant Total
    8
    Review Days
    314

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    Basic Information

    Device Name
    ZOOM-100DC
    K Number
    K082886
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brainscope Company, Inc.
    Date Received
    September 30, 2008
    Decision Date
    August 10, 2009
    Product Code
    OLT
    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
    OLT Non-Normalizing Quantitative Electroencephalograph Software

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    Other Clearances by Brainscope Company, Inc.

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