Catalog Number

-

Brand Name

Digital Electrocardiograph

Version/Model Number

iE10

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171517,K171517

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

46936acb-27ae-4ff8-9148-eaa1d8e9e8ee

Public Version Date

March 10, 2021

Public Version Number

5

DI Record Publish Date

January 30, 2018

Package DI Number

06937683413879

Quantity per Package

1

Contains DI Package

06937683413855

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-