Catalog Number

-

Brand Name

XLTEK

Version/Model Number

005039

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

K090019

Product Code

OMB

Product Code Name

Automatic Event Detection Software For Full-Montage Electroencephalograph

Public Device Record Key

bf0dad06-6a90-4616-bb58-d9afbb03d0f2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-