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510(k) Data Aggregation

    K Number
    K250106
    Device Name
    Signos Glucose Monitoring System
    Manufacturer
    Signos, Inc.
    Date Cleared
    2025-03-21

    (65 days)

    Product Code
    SAF
    Regulation Number
    862.1355
    Why did this record match?
    Applicant Name (Manufacturer) :

    Signos, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Signos Glucose Monitoring System is an over-the-counter (OTC) mobile device application that receives data from an integrated Continuous Glucose Monitor (iCGM) sensor and is intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. The Signos Glucose Monitoring System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Signos Glucose Monitoring System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursions. This information may be useful in helping users to maintain a healthy weight. The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.
    Device Description
    The Signos Glucose Monitoring System is a mobile device application that is paired, via Bluetooth®, with an over-the-counter interoperable continuous glucose monitor (iCGM). The application functions as a primary display for the iCGM by showing the user's glucose reading along with a historic trend every 15 minutes. The system is capable of backfilling missed data and supporting a grace period dictated by the iCGM. The system's various displays, text, graphs, suggestions, and notifications serve to clearly illustrate the user's past and present glucose readings and their trend direction to assist the user in maintaining a euglycemic state. The glucose display range is 70 mg/dL to 250 mg/dL. The Signos System is intended for users over the age of 18 not on insulin.
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