The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy…
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Listed by | Samsung Electronics Co., Ltd., South Korea |
| FDA product code | QDA |
| Device type | Electrocardiograph Software For Over-The-Counter Use |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2345 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K230292 |
| Record published | 2023-10-23 |
| Record revised | 2026-05-07 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.