Catalog Number

-

Brand Name

KardiaMobile 6L

Version/Model Number

AC-019

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K183319

Product Code

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

70c33eff-daae-42d1-9a2d-90d9bb16820a

Public Version Date

June 21, 2022

Public Version Number

3

DI Record Publish Date

May 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-