Catalog Number

-

Brand Name

eego

Version/Model Number

LE-200

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051825

Product Code

GWQ

Product Code Name

Full-montage Standard Electroencephalograph

Public Device Record Key

3d2f63ca-1cee-4677-9306-c6e87b05aacc

Public Version Date

May 08, 2020

Public Version Number

1

DI Record Publish Date

April 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-