7 devices · 7 companies · 2017 to 2025
Product code DPS: Electrocardiograph
7 devices under product code DPS, 2017 to 2025, from 7 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (7 of 7 here), the regulation, and MAUDE report counts by product code.
Electrocardiograph. 21 CFR 870.2340, Class II. MAUDE held 898 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 |
|---|---|---|---|---|
| Cardiologs Holter PlatformK250569 · 510(k) | Philips France Commercial | Cardiovascular | database entry | |
| ImpalaK232035 · 510(k) | AliveCor, Inc. | Cardiovascular | database entry | |
| Withings Scan Monitor 2.0K230812 · 510(k) | Withings | Cardiovascular | database entry | |
| AI-ECG TrackerK200036 · 510(k) | Shenzhen Carewell Electronics Co., Ltd. | Cardiovascular | database entry | |
| physIQ Heart Rhythm and Respiratory ModuleK183322 · 510(k) | physIQ, Inc | Cardiovascular | database entry | |
| Cardio-TriTest v6.5K182790 · 510(k) | Cardio-Phoenix Inc. | Cardiovascular | database entry | |
| CardioLogs ECG Analysis PlatformK170568 · 510(k) | Cardiologs Technologies | Cardiovascular | database entry |
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