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

    SmartBolus Calculator

    K Number: K222239 · Decision Aug 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    23
    Review Days
    24

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    Basic Information

    Device Name
    SmartBolus Calculator
    K Number
    K222239
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1358
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Insulet Corporation
    Date Received
    July 26, 2022
    Decision Date
    August 19, 2022
    Product Code
    QRX
    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
    QRX Continuous Glucose Monitor Informed Insulin Dose Calculator

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