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Samsung ECG Monitor App with Irregular Heart Rhythm Notification

FDA UDIEUDAMED

Class II (US FDA UDI)

by Samsung Electronics Co., Ltd.

Identity

Trade Name
Samsung ECG Monitor App with Irregular Heart Rhythm Notification FDA UDI
Generic Name
Self-care monitoring/reporting software FDA UDI
Device Name
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. FDA UDI
Model / Reference
1.X FDA UDI
Description
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. FDA UDI

Identifiers

Primary DI / UDI-DI
08806094940763 FDA UDI
510(k) Number
K230292 FDA UDI
FDA Product Code
QDA FDA UDI
QDB FDA UDI
GMDN Term
Self-care monitoring/reporting software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2345 FDA UDI
870.2790 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Self-care monitoring/reporting software

Samsung ECG Monitor App with Irregular Heart Rhythm Notification by Samsung Electronics Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Self-care monitoring/reporting software.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Samsung Electronics Co., Ltd.

Sources (2)

  • FDA UDI 79a20584-8685-457e-b26e-6d90dca27cf7 34 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026