1 0

    FDA 510(k), K120216, GENOSYL MV-1000

    FDA 510(k), K120216, GENOSYL MV-1000

    $89.00 USD
    $89.00 USD
    Sale Sold out
    510(K) Number: K120216
    Device Name: GENOSYL MV-1000
    Manufacturer:
    Device Classification Name: Apparatus, Nitric Oxide Delivery
    Regulation Number: 868.5165
    Classification Product Code: MRN
    Date Received: 01/24/2012
    Decision Date: 05/16/2012
    Regulation Medical Specialty: Anesthesiology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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

    View full details