Instrumentation Difra - The VISIOBOX allows to stimulate visually the - Instrumentation Difra SA

Duns Number:370173410

Device Description: The VISIOBOX allows to stimulate visually the patient for the diagnosis of its vestibular The VISIOBOX allows to stimulate visually the patient for the diagnosis of its vestibular system. With the help of your ENG/VNG system, it performs the calibration of the system and allows you to study eyes movements occurring during the following tests: random saccades, smooth pursuit and optokinetic.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

22186

Brand Name

Instrumentation Difra

Version/Model Number

VisioBox II

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

-

Product Code Details

Product Code

HOW

Product Code Name

Drum, Opticokinetic

Device Record Status

Public Device Record Key

a5de2285-a5c5-48cf-a5e4-8059087ae8ef

Public Version Date

October 18, 2018

Public Version Number

1

DI Record Publish Date

September 17, 2018

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