Instrumentation Difra - The Ideas III is an Electronystagmography (ENG) - Instrumentation Difra SA

Duns Number:370173410

Device Description: The Ideas III is an Electronystagmography (ENG) system. Electronystagmography measures eye The Ideas III is an Electronystagmography (ENG) system. Electronystagmography measures eye movements using the method of electro-oculography (EOG). In this method, skinmounted electrodes measure changes in potentials across the eyeball due to movement of the eye in its socket. The corneal retinal potential is the source of the measured voltage. Those movements are recorded and transmitted to a computer. The eye movement is analyzed by the software.Ideas III 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). Ideas III is able to record horizontal and vertical movements simultaneously on both eyes or on one eye only.

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More Product Details

Catalog Number

22315

Brand Name

Instrumentation Difra

Version/Model Number

Ideas III

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K070670

Product Code Details

Product Code

GWN

Product Code Name

Nystagmograph

Device Record Status

Public Device Record Key

67fba97f-29f2-40ef-a2db-3bbe7607a71e

Public Version Date

July 06, 2021

Public Version Number

1

DI Record Publish Date

June 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INSTRUMENTATION DIFRA SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 8