Samsung ECG Monitor App with Irregular Heart Rhythm Notification

GUDID 08806094948233

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 ID: 08806094948233
• NIH Device Record Key: 2b0027e3-f26a-4ca7-8ce6-ec5075c43b3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Samsung ECG Monitor App with Irregular Heart Rhythm Notification
• Version Model Number: 1.X
• Company DUNS: 687967554
• Company Name: Samsung Electronics Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806094948233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230292

FDA Product Code

• QDB: Photoplethysmograph Analysis Software For Over-The-Counter Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-31
• Device Publish Date: 2023-10-23

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

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