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    FDA 510(k) K002837, BIS ENGINE

    FDA 510(k) K002837, BIS ENGINE

    $139.31 USD
    $139.31 USD
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    Device Classification Name    Index-Generating Electroencephalograph Software
    510(k) Number    K002837
    Device Name    BIS ENGINE
    Applicant    ASPECT MEDICAL SYSTEMS, INC.
    Regulation Number    882.1400
    Classification Product Code    OLW  
    Subsequent Product Codes    OLT      OMC      ORT  
    Date Received    09/12/2000
    Decision Date    09/19/2000
    Decision    Substantially Equivalent (SESE)
    Regulation Medical Specialty    Neurology
    510k Review Panel    Neurology
    Type    Special
    Reviewed by Third Party    No
    Combination Product    No

    Total pages: 85
    Fully redacted pages: 30
    Content pages: 55

    PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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