Catalog Number

8-69-42630

Brand Name

GN Otometrics A/S

Version/Model Number

Monocular Oculomotor Limited

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K122550

Product Code

GWN

Product Code Name

Nystagmograph

Public Device Record Key

06de500c-7637-4aeb-ac6f-a529b059f0c9

Public Version Date

December 03, 2020

Public Version Number

2

DI Record Publish Date

October 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-