BEUDAMED
    Product Code: OZO FDA class 3

    Automated Insulin Dosing , Threshold Suspend

    Unknown

    The Automated Insulin Dosing, Threshold Suspend is a Class 3 diabetes management system that temporarily suspends or reduces insulin infusion from an insulin pump based on specified glucose level thresholds measured by a continuous glucose monitor, helping to prevent hypoglycemia. It is classified as Class 3 (FDA Class 3), requiring Premarket Approval (PMA) due to its automated and safety-critical insulin delivery function. The product code is OZO, reviewed under the clinical chemistry panel, with no regulation number assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    18
    Registration Numbers
    18
    Unique Applicants
    0
    Years Active
    —

    Basic Information

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

    Device Characteristics

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

    Definition

    An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.

    FEI Numbers

    This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.