DEVICE: Instrumentation Difra (B516221340)

Device Identifier (DI) Information

Instrumentation Difra
NysStar II
In Commercial Distribution
22134
Instrumentation Difra SA
B516221340
HIBCC

1
370173410 *Terms of Use
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electronystagmograph A graphic recorder used for detecting the electrical potential caused by eye movements. This recorder includes an electrode for each eye and one on the forehead (multichannel recording) for measuring the potential from both eyes simultaneously, or repositioning of the electrodes before each test for single channel recording. Electronystagmographs are used for detecting multiple sclerosis, vestibular dysfunctions, the presence of drugs and other specific disorders characterized by involuntary eye movement (nystagmus).
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FDA Product Code

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Product Code Product Code Name
GWN Nystagmograph
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K070670 000
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

fe804db4-90d8-4f55-aad7-471b2b8ef61b
July 06, 2018
3
May 19, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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