1 0

    FDA 510(k), K963817, LEVO MOBIL LCM

    FDA 510(k), K963817, LEVO MOBIL LCM

    $89.00 USD
    $89.00 USD
    Sale Sold out
    510(K) Number: K963817
    Device Name: LEVO MOBIL LCM
    Manufacturer:
    Device Classification Name: Wheelchair, Standup
    Regulation Number: 890.3900
    Classification Product Code: IPL
    Date Received: 09/23/1996
    Decision Date: 12/23/1997
    Regulation Medical Specialty: Physical Medicine

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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