Catalog Number

-

Brand Name

ImPACT Quick Test

Version/Model Number

2

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170551

Product Code

POM

Product Code Name

Computerized Cognitive Assessment Aid For Concussion

Public Device Record Key

378f1939-5acb-4e04-aeef-36825ddbf555

Public Version Date

March 15, 2021

Public Version Number

1

DI Record Publish Date

March 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-