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510(k) Data Aggregation

    K Number
    K964702
    Device Name
    EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800
    Manufacturer
    EUCLID SYSTEMS CORP.
    Date Cleared
    1997-05-20

    (176 days)

    Product Code
    MMQ
    Regulation Number
    886.1350
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUCLID SYSTEMS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Corneal Topographer: Indicated for use for measuring the shape and curvature of the anterior surface of the eye and for displaying the topographical maps of the surface of the cornea. This information can be used to analyze, monitor and evaluate the shape and symmetry of the comea following refractive surgery, to assist in the diagnosis of keratoconus, to assist in the fitting of contact lenses, to assist in the understanding of various corneal irregularities such as those induced by post operative sutures and wounds, and to assist in the understanding of various refractive conditions of the cornea, such as myopia, hyperopia, and astigmatism.
    Device Description
    Not Found
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