Catalog Number

-

Brand Name

cognitrace

Version/Model Number

LC-106

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

883ec533-7c79-4e41-a78b-73aac58822b9

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

-