QDA
9 FDA 510(k) clearances · Product code
122 daysmedian time to decision
450 days90th percentile
9clearances measured
FDA profile
- Official device name
- Electrocardiograph Software For Over-The-Counter Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2345
- Medical specialty
- Cardiovascular
- FDA definition
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Withings ECG App (K240795) | Withings | 2025-06-15 |
| WHOOP ECG (electrocardiogram) Feature (1.0) (K243236) | Whoop., Inc. | 2025-04-04 |
| Samsung ECG App v 1.3 (ECG) (K240909) | Samsung Electronics Co., Ltd. | 2024-08-02 |
| Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (K230292) | Samsung Electronics Co., Ltd. | 2023-05-02 |
| Garmin ECG App (K221774) | Garmin International, Inc. | 2023-01-12 |
| ECG App (K201525) | Apple, Inc. | 2020-10-08 |
| Fitbit ECG App (K200948) | Fitbit, Inc. | 2020-09-11 |
| ECG Monitor App (K201168) | Samsung Electronics Co., Ltd. | 2020-08-04 |
| ECG App (DEN180044) | Apple, Inc. | 2018-09-11 |
Track QDA automatically
Every clearance here is in the API, with alerts when new ones post.