Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (K230292)
Description
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification by Samsung Electronics Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230292
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Samsung ECG Monitor Application with Irregular Heart Rhythm Notification (K230292) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201168 | ECG Monitor App | Samsung Electronics Co., Ltd. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240909 | Samsung ECG App v 1.3 (ECG) | Samsung Electronics Co., Ltd. | 2024 |
Trace the full predicate network for K230292
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.