Samsung ECG Monitor App with Irregular Heart Rhythm Notification

GUDID 08806094940756

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.

Samsung Electronics Co., Ltd.

Self-care monitoring/reporting software
Primary Device ID08806094940756
NIH Device Record Key2b0027e3-f26a-4ca7-8ce6-ec5075c43b3d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSamsung ECG Monitor App with Irregular Heart Rhythm Notification
Version Model Number1.X
Company DUNS687967554
Company NameSamsung Electronics Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806094940756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-07-15
Device Publish Date2023-10-23

On-Brand Devices [Samsung ECG Monitor App with Irregular Heart Rhythm Notification]

08806094948240The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-coun
08806094948233The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-coun
08806094940763The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-coun
08806094940756The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-coun

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.