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510(k) Data Aggregation

    K Number
    K141862
    Device Name
    HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE
    Manufacturer
    Date Cleared
    2014-12-02

    (145 days)

    Product Code
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    H2 Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Health2Sync Mobile Application is data management software that is intended for use in home and professional settings to aid people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. The Health2Sync Smart Cable allows users to upload blood glucose data from compatible FDA cleared meters to the Health2Sync Mobile Application on their iPhone operating system platform. Health2Sync Mobile Application is not intended to provide treatment decisions nor is it to be used as a substitute for professional healthcare advice.
    Device Description
    The Health2Sync Mobile Application and Smart Cable (Mobile App and adapters) allows the transfer of blood glucose readings from the compatible glucose meter to smartphone via Smart Cable. The App features enable the user to view and analyze blood glucose readings from different meal time periods, other features including lifestyle diary, interpretable graphs option, inviting and sharing data with partners, and emailing reports are available for viewing and analyzing blood glucose readings within the different time slots. The system includes: 1) Health2Sync Mobile Application (through Apple store only), 2) Smart Cable, 3) Smart Cable 3.5mm connector (optional) and 4) Smart Cable and Application Quick Start Guide Compatible Meters include: OMNIS Health Embrace BGMS Meter, (k113098) OMNIS Health Embrace EVO BGMS Meter (k090043), and Medline EvenCare G2 BGMS meter (k113208)
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