Catalog Number

SY.VNS.WIFI

Brand Name

Complete Monocular wireless Smart Cam system with Goggles Flex

Version/Model Number

SY.VNS.WIFI

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

K163558

Product Code

GWN

Product Code Name

Nystagmograph

Public Device Record Key

0e203d69-e9d8-461b-b4d6-c39ca5b1a184

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-