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510(k) Data Aggregation

    K Number
    K083221
    Device Name
    AIDERA DIASEND
    Manufacturer
    AIDERA AB
    Date Cleared
    2009-02-03

    (95 days)

    Product Code
    MRZ,NBW
    Regulation Number
    880.5725
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K063484,K072698,K042768
    Predicate For
    K101806
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Diasend is intended for transmitting data from home monitoring devices such as glucose meters and insulin pumps to a server data base.

    Device Description

    Diasend is a system for transmitting of data from patients home monitoring devices and consists of a transmitter, a server database and a website available for the care provider and the patient.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted. The document is a 510(k) summary and FDA clearance letter for the Aidera Diasend System, which describes its intended use and classification but does not include details on performance studies or validation.

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