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510(k) Data Aggregation
K Number
K964325Device Name
VISUALEYES: VIDEO EYE MONITOR
Manufacturer
MICROMEDICAL TECHNOLOGIES, INC.
Date Cleared
1997-07-15
(258 days)
Product Code
GWN, 84G
Regulation Number
882.1460Why did this record match?
Applicant Name (Manufacturer) :
MICROMEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Eye Monitor is used to observe eye movements from various stimuli used in vestibular diagnostic testing. It allows observation of horizontal, vertical and torsional eye movements.
The Eye Monitor is mainly used to visually detect nystagmus positional maneuvers (e.g. Hallpike positional tests) or caloric tests. The device is especially useful in situations where the operator needs to observe the patient 's eyes to distinguish nystagmus from artifacts. These observations are currently done using Fresnel lenses.
The eye movements could also be recorded on suitable media (e.g. video tape) to provide documentation for any diagnosis based on observation of the Eye Monitor.
Device Description
Not Found
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K Number
K964646Device Name
VIDEO EYE TRAKKER
Manufacturer
MICROMEDICAL TECHNOLOGIES, INC.
Date Cleared
1997-07-15
(237 days)
Product Code
GWN, 84G
Regulation Number
882.1460Why did this record match?
Applicant Name (Manufacturer) :
MICROMEDICAL TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is used to non-invasively record horizontal and vertical eye movements of patients during routine electronystagmography (ENG) testing of vestibular function using miniature video cameras and pupil tracking hardware. The device is an alternative to skin electrodes and a paysiologic signal amplifier for monitoring eye position.
Device Description
Video Eye Trakker
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