Catalog Number

-

Brand Name

X-Series

Version/Model Number

XS10-4220

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131383

Product Code

GWQ

Product Code Name

Full-Montage Standard Electroencephalograph

Public Device Record Key

997689eb-9b73-4e54-92de-45f586b06411

Public Version Date

December 06, 2018

Public Version Number

4

DI Record Publish Date

January 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-