Panels › Cardiovascular › Product code QDA · Class 2
Electrocardiograph Software For Over-The-Counter Use
Regulation 870.2345
0510(k)s in 12 months (9 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QDA
| Company | 510(k)s | Recalls |
|---|---|---|
| Samsung Electronics Co., Ltd. | 3 | 0 |
| Apple, Inc. | 2 | 0 |
| Fitbit, Inc. | 1 | 0 |
| Garmin International, Inc. | 1 | 0 |
| Whoop., Inc. | 1 | 0 |
| Withings | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 2025 | K240795 | Withings ECG App Withings, FR | QDA |
| Apr 4, 2025 | K243236 | WHOOP ECG (electrocardiogram) Feature (1.0) Whoop., Inc. | QDA |
| Aug 2, 2024 | K240909 | Samsung ECG App v 1.3 (ECG) Samsung Electronics Co., Ltd., KR | QDA |
| May 2, 2023 | K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification Samsung Electronics Co., Ltd., KR | QDA |
| Jan 12, 2023 | K221774 | Garmin ECG App Garmin International, Inc. | QDA |
| Oct 8, 2020 | K201525 | ECG App Apple, Inc. | QDA |
| Sep 11, 2020 | K200948 | Fitbit ECG App Fitbit, Inc. | QDA |
| Aug 4, 2020 | K201168 | ECG Monitor App Samsung Electronics Co., Ltd., KR | QDA |
| Sep 11, 2018 | DEN180044 | ECG App Apple, Inc. | QDA |
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