Samsung ECG App v 1.3 (ECG)
FDA 510(k) K240909 · Samsung Electronics Co., Ltd.
510(k) numberK240909
Submission
- Device name
- Samsung ECG App v 1.3 (ECG)
- Applicant
- Samsung Electronics Co., Ltd.
Suwon-Si, KR - Received
- April 2, 2024
- Decision date
- August 2, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QDA – Electrocardiograph Software For Over-The-Counter Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2345
- Specialty
- Cardiovascular
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.
Other 510(k)s with product code QDA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240795 | Withings ECG AppQDA · Traditional | Withings | 06/15/2025SE |
| K243236 | WHOOP ECG (electrocardiogram) Feature (1.0)QDA · Traditional | Whoop., Inc. | 04/04/2025SE |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationQDA · Traditional | Samsung Electronics Co., Ltd. | 05/02/2023SE |
| K221774 | Garmin ECG AppQDA · Traditional | Garmin International, Inc. | 01/12/2023SE |
| K201525 | ECG AppQDA · Traditional | Apple, Inc. | 10/08/2020SE |
| K200948 | Fitbit ECG AppQDA · Traditional | Fitbit, Inc. | 09/11/2020SE |
| K201168 | ECG Monitor AppQDA · Traditional | Samsung Electronics Co., Ltd. | 08/04/2020SE |
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| K242478 | GF85 (models GF85-3P, GF85-SP)KPR · Traditional | 09/19/2024SE |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm NotificationQDA · Traditional | 05/02/2023SE |
| K222353 | GM85IZL · Traditional | 09/29/2022SE |
| K220175 | GM85IZL · Traditional | 04/21/2022SE |
| K213452 | Gems-HPHL · Traditional | 04/21/2022SE |
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Questions and answers
When was Samsung ECG App v 1.3 (ECG) cleared by the FDA?
Samsung ECG App v 1.3 (ECG) (K240909) received a 510(k) decision of Substantially Equivalent on August 2, 2024, 122 days after the submission was received.
What is the product code of K240909?
The FDA product code is QDA – Electrocardiograph Software For Over-The-Counter Use, a Class II (moderate risk) device regulated under 21 CFR 870.2345.