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    FDA 510(k) K200107, epoc Blood Analysis System, by Epocal, Inc.

    FDA 510(k) K200107, epoc Blood Analysis System, by Epocal, Inc.

    $3,500.00 USD
    $3,500.00 USD
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    Device Classification Name: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
    510(k) Number: K200107
    Device Name: epoc Blood Analysis System
    Applicant: Epocal, Inc.
    Regulation Number: 862.1120
    Classification Product Code: CHL
    Date Received: 01/17/2020
    Decision Date: 06/05/2020
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Clinical Chemistry
    510k Review Panel: Clinical Chemistry

    Total number of pages: 7,239
    Fully redacted pages: 3,779
    Content pages: 3,460

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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