BEUDAMED
    Product Code: QVE FDA class 2 21 CFR 868.2200

    Adjunctive Pain Measurement Device For Anesthesiology

    Anesthesiology

    The Adjunctive Pain Measurement Device for Anesthesiology is a prescription device that uses software algorithms to analyze physiological sensor data and quantify a patient's response to painful stimuli during general anesthesia, assisting anesthesiologists in tailoring analgesic administration more precisely. The device may be software-only or include hardware sensors, and is intended for adjunctive use alongside clinical judgment rather than independently directing care. Classified as FDA Class 2 under regulation 868.2200, it requires 510(k) clearance in the Anesthesiology specialty. It is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    QVE
    Device Class
    FDA class 2
    Regulation Number
    868.2200
    Medical Specialty
    Anesthesiology
    Review Panel
    AN
    Submission Type
    1

    Device Characteristics

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

    Definition

    An adjunctive pain measurement device for anesthesiology is a prescription device that includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. The device may be software-only or it may include hardware such as physiological sensors. This device type is intended for adjunctive use to tailor analgesic administration to a patient’s actual response to painful stimuli and is not intended to independently direct decision-making.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN210022 PMD-200

    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.