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510(k) Data Aggregation
K Number
K070670Device Name
EYETRACKER/IDEAS
Manufacturer
Date Cleared
2007-09-18
(190 days)
Regulation Number
882.1460Why did this record match?
Applicant Name (Manufacturer) :
S.A. INSTRUMENTATION DIFRA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended to measure, record and display the movements of the eyeballs during their involuntary movements (nystagmus) and while testing the patient's vestibular function.
The device is for prescription use only and it is intended for use by qualified medical personnel trained in the use of nystagmographs. This device provides no diagnoses nor does it provide diagnostic recommendations.
Device Description
The device is a PC-based system for measuring, recording and displaying the eve movements. Its components include video goggles or surface electrodes to record the eve movements, a PC interface to acquire the data, a series of software modules to display and analyze the data and various stimulation devices.
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