Catalog Number

-

Brand Name

BIS

Version/Model Number

186-0106-PH

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,K093183,K072286,K093183

Product Code

OLW

Product Code Name

Index-generating electroencephalograph software

Public Device Record Key

1ed1567d-f801-40de-b79b-3d0b4fa512c2

Public Version Date

October 13, 2022

Public Version Number

7

DI Record Publish Date

October 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-