ECG App
FDA 510(k) clearance DEN180044 · decided 2018-09-11
Clearance details
- K-number
- DEN180044
- Device name
- ECG App
- Applicant
- Apple, Inc.
- Decision
- Unknown
- Date received
- 2018-08-14
- Decision date
- 2018-09-11
- Days to decision
- 28 days
- Clearance type
- Direct
- Product code
- QDA
- Device class
- 2
- Regulation number
- 870.2345
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Alexandria, VA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
No recalls on record reference this clearance.