Cardiology
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
Samsung Electronics Co., Ltd
FDA-cleared AI medical device
An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.
FDA Submission Metadata
- Submission number
- K230292
- Decision date
- May 2023
- FDA panel
- Cardiovascular
- Product code
- QDA
- Clinical task (npj)
- triage
- Data modality (npj)
- Signals
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.