Catalog Number

91482

Brand Name

UltraviewSL

Version/Model Number

91482

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

K060900

Product Code

OLT

Product Code Name

Non-normalizing quantitative electroencephalograph software

Public Device Record Key

14170906-4a58-4422-9490-3a503eb01eb5

Public Version Date

January 08, 2020

Public Version Number

5

DI Record Publish Date

October 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-