Catalog Number

-

Brand Name

AE-120A EEG Head Set

Version/Model Number

NE-091S7

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

Yes

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,K183529

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

2e398ffc-4a29-4407-85b0-05f2fd9644cb

Public Version Date

June 14, 2019

Public Version Number

1

DI Record Publish Date

June 06, 2019

Package DI Number

14931921903046

Quantity per Package

6

Contains DI Package

04931921903049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-