Catalog Number

NE-118A

Brand Name

AE-120A EEG Head Set

Version/Model Number

NE-118A

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

K183529

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

89461758-6ee4-4133-bd0c-404dc4a853b5

Public Version Date

June 21, 2019

Public Version Number

1

DI Record Publish Date

June 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-