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510(k) Data Aggregation

    K Number
    K241803
    Device Name
    INSULCLOCK® v2.0 PRO
    Manufacturer
    Insulcloud S.L.
    Date Cleared
    2024-08-22

    (62 days)

    Product Code
    QOG
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Insulcloud S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Insulclock® is for use by patients using disposable insulin diagnosed with type I or type II diabetes mellitus. - Insulclock® is for use by people from 18 to 65 years old. Out of this age range, the Insulclock® must be used under supervision. - Insulclock® is designed for use in any home environment. - Using a compatible App. INTENDED USE: INSULCLOCK® v2.0 pro is intended to detect, store and transfer insulin dose-related data, the time of injection and the temperature to which the disposable insulin pen has been exposed to. All this information is sent to a mobile app via integrated SDK.
    Device Description
    The INSULCLOCK® v2.0 pro is a reusable data transmitter with Software Development Kit (SDK) that detects and stores insulin dose- related data when attached to a disposable insulin pen and then transfers information to a compatible mobile application via Bluetooth® wireless technology which can display the brand of insulin, dose amount, injection time, and ambient temperature. Models: - INSULCLOCK® v2.0 PRO for Kwikpen® (Lilly®) - INSULCLOCK® v2.0 PRO for Flex-touch® (Novo Nordisk®)
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