FDA Product Code
FDA Product Code QDA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2345
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240795 | Withings ECG App | Withings | 2025-06-15 | Traditional | PDF ↗ |
| K243236 | WHOOP ECG (electrocardiogram) Feature (1.0) | Whoop., Inc. | 2025-04-04 | Traditional | PDF ↗ |
| K240909 | Samsung ECG App v 1.3 (ECG) | Samsung Electronics Co., Ltd. | 2024-08-02 | Traditional | PDF ↗ |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd. | 2023-05-02 | Traditional | PDF ↗ |
| K221774 | Garmin ECG App | Garmin International, Inc. | 2023-01-12 | Traditional | PDF ↗ |
| K201525 | ECG App | Apple, Inc. | 2020-10-08 | Traditional | PDF ↗ |
| K200948 | Fitbit ECG App | Fitbit, Inc. | 2020-09-11 | Traditional | PDF ↗ |
| K201168 | ECG Monitor App | Samsung Electronics Co., Ltd. | 2020-08-04 | Traditional | PDF ↗ |
| DEN180044 | ECG App | Apple, Inc. | 2018-09-11 | Direct | — |
Product code QDA · Class II · Cardiovascular. Data: openFDA.