Catalog Number

821401000000

Brand Name

INTELLISPACE™ COGNITION

Version/Model Number

1.1.X

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 27, 2020

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

-

Product Code

PTY

Product Code Name

Computerized Cognitive Assessment Aid, Exempt

Public Device Record Key

58eda8f9-3eb5-4ed9-9f64-03c7d2bac6bc

Public Version Date

August 06, 2020

Public Version Number

2

DI Record Publish Date

October 30, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-