BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Bigfoot Unity® Diabetes Management System

    K Number: K222280 · Decision Mar 1, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    8
    Applicant Total
    2
    Review Days
    215

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    Basic Information

    Device Name
    Bigfoot Unity® Diabetes Management System
    K Number
    K222280
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1355
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bigfoot Biomedical, Inc.
    Date Received
    July 29, 2022
    Decision Date
    March 1, 2023
    Product Code
    QLG
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

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    Other Clearances by Bigfoot Biomedical, Inc.

    K Number Device Name
    K202145 Bigfoot Unity Diabetes Management System