2 devices · 2 companies · 2023 to 2025
Product code QDA: Electrocardiograph Software For Over-The-Counter Use
2 devices under product code QDA, 2023 to 2025, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Electrocardiograph Software For Over-The-Counter Use. 21 CFR 870.2345, Class II. 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. MAUDE held 37 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Withings ECG AppK240795 · 510(k) | Withings | Cardiovascular | database entry | |
| Samsung ECG Monitor Application with Irregular HK230292 · 510(k) | Samsung Electronics Co., Ltd | Cardiovascular | database entry |
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