Catalog Number

ATLAS Neurophysiology System

Brand Name

ATLAS Neurophysiology System

Version/Model Number

ATLAS Neurophysiology System

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

K110967

Product Code

OMC

Product Code Name

Reduced- Montage Standard Electroencephalograph

Public Device Record Key

06788d4c-764f-459c-940f-5401db680e94

Public Version Date

November 28, 2019

Public Version Number

4

DI Record Publish Date

July 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-