Catalog Number

-

Brand Name

eMotion ECG

Version/Model Number

eMotion ECG sensor

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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

K131699

Product Code

DXH

Product Code Name

Transmitters And Receivers, Electrocardiograph, Telephone

Public Device Record Key

21629256-43fa-49b2-ac09-21bb847f7965

Public Version Date

December 31, 2021

Public Version Number

8

DI Record Publish Date

September 22, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-