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    K Number
    K063873
    Device Name
    ICARE TONOMETER TA01I
    Manufacturer
    TIOLAT OY
    Date Cleared
    2007-05-23

    (145 days)

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

    TIOLAT OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iCare Tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.
    Device Description
    The iCare Tonometer TA01i is a portable, handheld, battery operated tonometer, which measures intraocular pressure (IOP). To measure IOP, a very light (26.5 mg) and a slow moving (0.25-0.30 m/s) probe makes momentary contact with the cornea of the eye. The device measures the speed of the probe during the time probe is in contact with cornea. Resulting IOP is displayed on a liquid crystal display (LCD). The force used for the measurement which is directed onto the eye is extremely small, because of the low weight and slow speed of the probe.
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