FDA 510(k) · Samsung
K201168: ECG Monitor App (Samsung Electronics Co., Ltd.)
Samsung Electronics Co., Ltd. received FDA 510(k) K201168 for ECG Monitor App, with a decision date of Aug 4, 2020 (substantially equivalent).
Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K201168 |
|---|---|
| Pathway | 510(k) |
| Applicant | Samsung Electronics Co., Ltd. |
| Device name | ECG Monitor App |
| Product code | QDA: Electrocardiograph Software For Over-The-Counter Use |
| Regulation (21 CFR) | 870.2345 |
| Device class | Class 2 |
| Date received | May 1, 2020 |
| Decision date | Aug 4, 2020 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The Samsung ECG Monitor Application is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone. The app is intended to create, record, store, transfer, and display a single channel electrocardiogram (ECG), similar to a Lead I ECG, for informational use only in adults 22 years and older. Classifiable traces are labeled by the app as either atrial fibrillation (AFib) or sinus rhythm with the intention of aiding heart rhythm identification; it is not intended to replace traditional methods of diagnosis or treatment. The app is not intended for users with other known arrhythmias and users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. K201168
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- DEN180044 ECG App (Apple)
Later records that cite K201168
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code QDA is "Electrocardiograph Software For Over-The-Counter Use", class 2, 21 CFR 870.2345. FDA's definition: "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."
Our labels for filtering: claim ECG, sensor ECG electrodes. These are heuristics, not FDA fields.