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    FDA 510(k), K854903, GORDON DIAGNOSTIC SYSTEM MODEL I

    FDA 510(k), K854903, GORDON DIAGNOSTIC SYSTEM MODEL I

    $89.00 USD
    $89.00 USD
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    510(K) Number: K854903
    Device Name: GORDON DIAGNOSTIC SYSTEM MODEL I
    Manufacturer:
    Device Classification Name: Recorder, Attention Task Performance
    Regulation Number:
    Classification Product Code: LQD
    Date Received: 12/09/1985
    Decision Date: 06/02/1986
    Regulation Medical Specialty:

    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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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