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

    Control-IQ Technology

    K Number: K232382 · Decision Nov 3, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    19
    Applicant Total
    25
    Review Days
    87

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    Basic Information

    Device Name
    Control-IQ Technology
    K Number
    K232382
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1356
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tandem Diabetes Care, Inc.
    Date Received
    August 8, 2023
    Decision Date
    November 3, 2023
    Product Code
    QJI
    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
    QJI Interoperable Automated Glycemic Controller

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