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    K Number
    K021937
    Device Name
    TGDC-01 PRA
    Manufacturer
    TRUEVISION INSTRUMENTS
    Date Cleared
    2002-10-11

    (121 days)

    Product Code
    HKX
    Regulation Number
    886.1930
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    TRUEVISION INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TGDC - 01 PRA Tonometer is used to measure ocular pressure (IOP) in the diagnosis for use. The intended device is 0, 1101.
    Device Description
    The TGDc-01 "PRA" is a portable tonometer that measures IOP through the eyelid in the sclera area. It has a measurement range of 5-60 mm Hg, a single measurement time of not more than 3 seconds, and uses 2 CR2032 batteries. It weighs not more than 79 g and has dimensions of 173.5 x 25.5 x 19.5 mm. It displays the IOP measurement on an LCD screen.
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