1 0

    FDA 510(k) K032716, PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE), by Portex , Ltd.

    FDA 510(k) K032716, PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE), by Portex , Ltd.

    $341.30 USD
    $341.30 USD
    Sale Sold out

    Device Classification Name: Filter, Bacterial, Breathing-Circuit
    510(k) Number: K032716
    Device Name: PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)
    Applicant: Portex , Ltd.
    Regulation Number: 868.526
    Classification Product Code: CAH
    Date Received: 09/02/2003
    Decision Date: 11/28/2003
    Decision: Substantially Equivalent (SESE)
    Regulation Medical Specialty: Anesthesiology
    510k Review Panel: General Hospital

    Total number of pages: 154
    Fully redacted pages: 70
    Content pages: 84

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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