1 0

    FDA 510(k), K191660, CARTO 3 EP Navigation System, Version 7.1 and Accessories

    FDA 510(k), K191660, CARTO 3 EP Navigation System, Version 7.1 and Accessories

    $881.82 USD
    $881.82 USD
    Sale Sold out

    510(K) Number: K191660
    Device Name: CARTO 3 EP Navigation System, Version 7.1 and Accessories
    Manufacturer: Phuong Chau
    Device Classification Name: Computer, Diagnostic, Programmable
    Regulation Number: DQK
    Classification Product Code: KXA
    Date Received: 06/21/2019
    Decision Date: 07/20/2019
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Cardiovascular

    428 pages (72 of 500 original pages are fully redacted)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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