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    FDA 510(k), K141997, CRIT-LINE IV SYSTEM

    FDA 510(k), K141997, CRIT-LINE IV SYSTEM

    $561.89 USD
    $561.89 USD
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    510(K) Number: K141997
    Device Name: CRIT-LINE IV SYSTEM
    Manufacturer: DENISE OPPERMANN
    Device Classification Name: Accessories, Blood Circuit, Hemodialysis
    Regulation Number: KOC
    Classification Product Code: KXA
    Date Received: 07/23/2014
    Decision Date: 04/01/2015
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Gastroenterology/Urology

    Total pages: 936
    Fully redacted pages: 712
    Content pages: 224

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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