U.S. Food and Drug Administration

K243236

Cleared: April 4, 2025

Over-the-counter ECG software feature for detection of atrial fibrillation (AFib), normal sinus rhythm, low heart rate, and high heart rate. Intended for adults 22 years of age and older.

K240929

Cleared: September 13, 2024

Sleep apnea notification feature for detecting signs of moderate to severe obstructive sleep apnea in users aged 18+ without prior diagnosis

K240909

Cleared: August 2, 2024

Samsung ECG with IHRN 2.0 for ECG classification including high heart rate and atrial fibrillation with high heart rate

K213971

Cleared: June 6, 2022

AFib History Feature for providing retrospective estimate of AFib burden to users aged 22+ with diagnosed AFib

K201525

Cleared: December 15, 2020

ECG app update for detecting Atrial Fibrillation with high heart rate

K201168

Cleared: August 20, 2020

Samsung ECG Monitor App for creating, recording, storing, transferring, and displaying single-channel ECG for classification as atrial fibrillation or sinus rhythm in adults 22 years and older

DEN230041

Cleared: February 6, 2024

Over-the-counter device to assess risk of moderate to severe obstructive sleep apnea (OSA) in adults 22 years of age and older who have not been diagnosed with sleep apnea

DEN180044

Cleared: September 11, 2018

ECG app for creating, recording, storing, and displaying a single channel ECG for heart rhythm classification as Atrial Fibrillation or Sinus Rhythm

DEN180042

Cleared: September 11, 2018

Irregular Rhythm Notification Feature for detecting irregular heart rhythms suggestive of atrial fibrillation