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510(k) Data Aggregation
K Number
K964702Device Name
EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800
Manufacturer
EUCLID SYSTEMS CORP.
Date Cleared
1997-05-20
(176 days)
Product Code
MMQ
Regulation Number
886.1350Why 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
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