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    K Number
    K160613
    Device Name
    Soberlink Cellular Device and Sober Sky Web Portal
    Manufacturer
    SOBERLINK HEALTHCARE LLC
    Date Cleared
    2016-07-14

    (133 days)

    Product Code
    DJZ
    Regulation Number
    862.3050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOBERLINK HEALTHCARE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use The Soberlink Cellular Device is intended to quantitatively measure alcohol in human breath. Indications for Use Measurements obtained by this device are used in the diagnosis of alcohol intoxication. For Prescription use and OTC use.
    Device Description
    The Soberlink Cellular Device is a handheld breath alcohol measurement device with integrated GPS, digital imager, and cellular modem. It is designed to take a deep lung sample of the User's breath, calculate their Blood Alcohol Level (BAC), and send the BAC reading, physical location, and digital image of the User to the Sober Sky Web Portal and Device screen for review.
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