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

    Basal-IQ Technology

    K Number: K193483 · Decision Feb 28, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    0
    Applicant Total
    25
    Review Days
    73

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    Basic Information

    Device Name
    Basal-IQ Technology
    K Number
    K193483
    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
    December 17, 2019
    Decision Date
    February 28, 2020
    Product Code
    QJS
    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
    QJS Interoperable Automated Glycemic Controller, Insulin Suspend

    Other Clearances by Tandem Diabetes Care, Inc.

    K Number Device Name
    K260429 Control-IQ+ technology
    K253074 Tandem Mobi insulin pump with interoperable technology
    K250792 t:slim X2 insulin pump with interoperable technology
    K250798 Control-IQ+ technology
    K243823 Control-IQ+ technology
    K241078 Tandem Mobi Insulin Pump with interoperable technology
    K240309 Tandem Mobi insulin pump with interoperable technology
    K232380 t:slim X2 Insulin Pump with Interoperable Technology
    K232382 Control-IQ Technology
    K233044 Tandem Mobi insulin pump with interoperable technology
    Search all 25 clearances from Tandem Diabetes Care, Inc. →