BEUDAMED
    Product Code: OZQ FDA class 3

    Automated Insulin Dosing Device System, Bihormonal Control

    Unknown

    The Automated Insulin Dosing Device System, Bihormonal Control is a bihormonal automated closed-loop system that achieves a target glucose level by automatically adjusting two glucose-modulating therapies (such as insulin and glucagon) delivered via an infusion pump, with hormone adjustments based on measured glucose thresholds. It is classified as Class 3 (FDA Class 3), requiring Premarket Approval (PMA) due to the complexity and risk of dual-hormone automated delivery. The product code is OZQ, reviewed under the clinical chemistry panel, with no regulation number assigned.

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    Basic Information

    Product Code
    OZQ
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    CH
    Submission Type
    2

    Device Characteristics

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

    Definition

    A bihormonal automated insulin dosing system that achieves a target glucose level by automatically adjusting two glucose modulating therapies from an infusion pump. Hormone adjustments are based upon specified thresholds of measured glucose levels.