Catalog Number

31-0602-0029

Brand Name

ATLAS ANALOG ISOLATOR

Version/Model Number

ATLAS ANALOG ISOLATOR

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

f904f4fd-273f-403b-abdc-e6fc392dd6d1

Public Version Date

January 23, 2020

Public Version Number

1

DI Record Publish Date

January 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-