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510(k) Data Aggregation
K Number
K100095Device Name
CENTRAL VISION ANALYZER MODEL 1000
Manufacturer
VIMETRICS,LLC.
Date Cleared
2010-05-10
(117 days)
Product Code
HOX
Regulation Number
886.1150Why did this record match?
Product Code :
HOX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CVA-1000 is intended for use under the direct supervision of an ophthalmologist or optometrist in the measurement of vision at fixation in one or both eyes, with or without optical correction.
Device Description
The CVA-1000 instrument is a standalone device consisting of a computer processing unit with data storage, two LCD monitors, a physician viewed monitor and a patient viewed monitor, and connected keyboard and mouse for physician interaction with a response pad for patient interaction. The instrument provides an evaluation of vision at fixation of one or both eyes under different conditions of contrast and lighting assisting the ophthalmologist or optometrist in evaluating the effects of prescribed refractive instruments such as spectacles or contact lenses and of pharmaceutical treatment or surgical procedures on the central vision of one or both eyes.
The instrument may be used in either of two methods of operation: Chart Panel or Interactive Central Vision Panel.
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