510(k) K201168
- Device
- ECG Monitor App
- Applicant
- Samsung Electronics Co., Ltd
- 510(k) number
- K201168
- Product code
- QDA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-08-04
- Date received
- 2020-05-01
- Regulation
- 870.2345
- Classification name
- Electrocardiograph Software For Over-the-counter Use
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Taejong Jay Yang
- Address
- 129 Samsung-Ro, Yeongtong-Gu Suwon-Si KR 16677 16677
FDA Registration Numbers#
- 3009715978
- 3012516456
- 3009253624
- 3015134086
- 1000500214
- 8030245
- 3013896610
- 3017616353
- 3012302888
- 3031627845
- 3014522540
- 3011235999
- 3007184699
- 3008820594
- 9611045
- 1450057
- 3014343954
- 3006371704
Source Documents#
Other 510(k) Records For Product Code QDA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240795 | Withings ECG App | Withings | 2025-06-15 |
| K243236 | WHOOP ECG (electrocardiogram) Feature (1.0) | Whoop., Inc. | 2025-04-04 |
| K240909 | Samsung ECG App v 1.3 (ECG) | Samsung Electronics Co., Ltd. | 2024-08-02 |
| K230292 | Samsung ECG Monitor Application with Irregular Heart Rhythm Notification | Samsung Electronics Co., Ltd. | 2023-05-02 |
| K221774 | Garmin ECG App | Garmin International, Inc. | 2023-01-12 |
| K201525 | ECG App | Apple, Inc. | 2020-10-08 |
| K200948 | Fitbit ECG App | Fitbit, Inc. | 2020-09-11 |
| DEN180044 | ECG App | Apple, Inc. | 2018-09-11 |
Legacy Summary#
summary
FDA Review#
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