Catalog Number

HCEKGBTPEN30

Brand Name

HeartCheck BT PEN Handheld ECG

Version/Model Number

HCEKGBTPEN30

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121009

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

27a6c764-e1bd-4634-be24-0bec58e7e918

Public Version Date

March 10, 2021

Public Version Number

5

DI Record Publish Date

November 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-