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510(k) Data Aggregation

    K Number
    K232603
    Device Name
    CamAPS FX
    Manufacturer
    CamDiab Ltd.
    Date Cleared
    2024-05-23

    (269 days)

    Product Code
    QJI, NDC
    Regulation Number
    862.1356
    Why did this record match?
    Applicant Name (Manufacturer) :

    CamDiab Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CamAPS FX is a mobile app intended for managing glucose levels in people with type 1 diabetes, aged 2 years and over, using a hybrid closed loop approach (automated basal insulin delivery with manual bolusing for meals). Additional age and other restrictions may apply depending on the chosen continuous glucose monitor and insulin pump. CamAPS FX requires an insulin pump and a continuous glucose monitor (CGM) to fulfil its intended use. The list of supported insulin pumps and CGMs is provided in the User Manual. CamAPS FX is indicated for use in pregnancy complicated by type 1 diabetes provided that the linked continuous glucose monitoring system is suitable for use in pregnancy. CamAPS FX is for prescription use only.
    Device Description
    CamAPS FX is a mobile app.
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