Catalog Number

-

Brand Name

BIS

Version/Model Number

186-0224-SF

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

K072286

Product Code

OLW

Product Code Name

Index-generating electroencephalograph software

Public Device Record Key

ffe61a92-8521-4e6f-b300-9dff558c63d9

Public Version Date

April 08, 2022

Public Version Number

3

DI Record Publish Date

February 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-