BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)

    K Number: K032716 · Decision Nov 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    141
    Registration Numbers
    141
    Same Product Code
    201
    Applicant Total
    7
    Review Days
    87

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    Basic Information

    Device Name
    PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)
    K Number
    K032716
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5260
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Portex , Ltd.
    Date Received
    September 2, 2003
    Decision Date
    November 28, 2003
    Product Code
    CAH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CAH Filter, Bacterial, Breathing-Circuit

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