(88 days)
The Ulmer Video Nystagmograph System is intended for use by the physician as an aid for the detection and diagnosis of vestibular disorders. The Ulmer VNG detects and displays eye position and movement in response to a number of vestibular stimulations, i.e. saccadic test, smooth pursuit, optokinetic nystagmus, caloric tests, and kinetic vestibular tests. The Ulmer VNG records and analyzes the bilateral, monocular, horizontal, and vertical aspects of eye position and movement. This device is intended to be used in a doctor's office or health care facility to obtain recorded data of nystagmus by directly observing eye motion by videocameras. The resulting recorded data is evaluated by a trained physician and considered along with other relevant data in diagnosing vestibular disorders.
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§ 882.1460 Nystagmograph.
(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).