1 0

    FDA 510(k) K131908, 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC), by Fresenius Medical Care Renal Therapies Group, LLC

    FDA 510(k) K131908, 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC), by Fresenius Medical Care Renal Therapies Group, LLC

    $1,461.02 USD
    $1,461.02 USD
    Sale Sold out

    Device Classification Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
    510(k) Number: K131908
    Device Name: 2008T HEMODIALYSIS MACHINE WITH OPTIONAL CRIT-LINE MONITOR (CLIC)
    Applicant: Fresenius Medical Care Renal Therapies Group, LLC
    Regulation Number: 876.5860
    Classification Product Code: KDI
    Date Received: 06/26/2013
    Decision Date: 10/11/2013
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Gastroenterology/Urology
    510k Review Panel: Gastroenterology/Urology

    Total number of pages: 4,206
    Fully redacted pages: 3,623
    Content pages: 583

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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