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510(k) Data Aggregation

    K Number
    K991840
    Device Name
    FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER
    Manufacturer
    BERNARD B. FRESCO
    Date Cleared
    2000-03-20

    (297 days)

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

    BERNARD B. FRESCO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Clinical testing of intraocular pressure . Self testing of intraocular pressure. Home monitoring of intraocular pressure. Screening studies, and outreach clinics. For Glaucoma, Ocular hypertensive, and general population groups.
    Device Description
    The phosphene tonometer is a pressure measuring device which consists of three ABS plastic components which are moulded, and a stainless 312 metal spring. These fit together and comprise the body of the instrument, a probe with the spring within and a fiduciary, with reset potential.
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