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510(k) Data Aggregation

    K Number
    K032769
    Device Name
    EYESOPEN TONOMETER
    Manufacturer
    Date Cleared
    2003-09-23

    (15 days)

    Product Code
    Regulation Number
    886.1930
    Why did this record match?
    Applicant Name (Manufacturer) :

    EYE-DEAS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EYE-deas EyesOPen tonometer is used to measure the intraocular pressure (IOP) during routine eye examinations or when an increased IOP is suspected.
    Device Description
    The Eye-deas EyesOPen tonometer is a precision electronic tonometer, which measures intraocular pressure (IOP). The body of the instrument is specially designed to fit comfortably in the user's hand, facilitating fast and accurate measurements. The EyesOPen tonometer contains a solid-state force transducer and a CMOS image transducer that together produces electrical signals from which intraocular pressure is derived. When sufficient valid readings are obtained an IOP reading is displayed on a liquid crystal display. Under each of the four digits are bars. The bars correspond to the goodness of fit to a linear regression of pressure against applanated diameter. The regression coefficient is 95% or better if the first bar is illuminated, 90%-95% if the second bar is illuminated, 80%-90% if the third bar is illuminated, or less than 80% if the fourth bar is illuminated.
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