1 0

    FDA 510(k), K133598, CARDIOHELP SYSTEM

    FDA 510(k), K133598, CARDIOHELP SYSTEM

    $89.00 USD
    $89.00 USD
    Sale Sold out
    510(K) Number: K133598
    Device Name: CARDIOHELP SYSTEM
    Manufacturer:
    Device Classification Name: Console, Heart-Lung Machine, Cardiopulmonary Bypass
    Regulation Number: 870.4220
    Classification Product Code: DTQ
    Date Received: 11/22/2013
    Decision Date: 05/21/2014
    Regulation Medical Specialty: Cardiovascular

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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