BEUDAMED
    Product Code: QOR FDA not classified

    Continuous Ventilator, Minimal Ventilatory Support

    Unknown

    The Continuous Ventilator for Minimal Ventilatory Support (Emergency Use) is a ventilator intended to provide minimal ventilatory support by mechanically controlling or assisting patient breathing during a declared public health emergency. Authorized under an FDA EUA, it is not formally classified by device class. Product code QOR, reviewed by the Anesthesiology panel. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    QOR
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    AN
    Submission Type
    8

    Device Characteristics

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

    Definition

    A continuous ventilator (respirator) for emergency use that is intended to provide minimal ventilatory support to mechanically control or assist patient breathing during declared public health emergency.

    Unclassified Reason

    11

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.