Catalog Number

SVNG

Brand Name

I-Portal Super VNG

Version/Model Number

SVNG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

K143607

Product Code

GWN

Product Code Name

Nystagmograph

Public Device Record Key

cf072a12-dc07-4c4a-a0e2-7efa05e1dbe3

Public Version Date

November 19, 2020

Public Version Number

4

DI Record Publish Date

January 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-