KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L Max

Primary DI

B210AC0190

Brand

KardiaMobile 6L System, KardiaMobile 6L Max, Kardia 6L Max

Company

Alivecor, Inc.

Model

AC-019

Device description

KardiaMobile 6L System is a 3-electrode personal EKG device that is capable of recording two kinds of EKGs: a Single-Lead EKG and a Six-Lead EKG, which provides more data for you to share with your doctor. Both EKG types detect normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and indeterminate results (errors or unclassified rhythms). The KardiaMobile 6L System hardware has two electrodes on the top surface and one on the bottom surface. It is powered by a replaceable battery, which is located under the bottom electrode. Bluetooth is used to wirelessly transmit EKG data from the device to your smartphone or tablet.

Published

2020-05-01

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

OTC

true

Sterile

false

Single use

false