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510(k) Data Aggregation

    K Number
    K190382
    Device Name
    Intraocular Pressure Tonometer EASYTON
    Manufacturer
    Company Elamed
    Date Cleared
    2019-12-06

    (290 days)

    Product Code
    HKX
    Regulation Number
    886.1930
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    Applicant Name (Manufacturer) :

    Company Elamed

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tonometer Easyton is indicated for the measurement of intraocular pressure in human eyes.
    Device Description
    The principle of EASYTON measurement is based on simultaneous use of the two types of measuring actions – static and dynamic. Both actions are carried out by the vibrator's rod on the eyelid. Static action is carried out during the time of measurement and determined by the weight of the vibrator. Dynamic exposure represents itself during the vibrating action with frequency: about 150 HZ and amplitude: the millimeter hundredth parts and tactile is felt as soft vibration. Vibrator's rod is elastically movable in its axial direction and is set in oscillatory motion by electromagnetic way. While carrying out the measurement, the rod is put up on the eyelid, sagging (pressing the eyelid down with its weight about 10g and is fixed on sclera or an eye cornea forming elastic system of eye-vibrator with total mechanical rigidity. This system is disturbed from the equilibrium state by the rod's short term electromagnetic removal. In a system within tan equilibrium state restoration there are arising free damped vibration. Functional connection between elastic system rigidity and the period of is own vibration is known. This period is measured by the tonometer and is used for IOP calculation being shown on the display.
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