BEUDAMED
    Product Code: MWG FDA class 3

    System, Oxygen, Aqueous

    Unknown

    An Aqueous Oxygen System is a device that delivers oxygen dissolved in aqueous solution to tissues or body cavities, proposed for therapeutic applications such as intraperitoneal oxygenation or other specialized delivery contexts. It is classified as FDA Class 3, requiring PMA approval, with product code MWG. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    MWG
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    CV
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.