1 device · 1 company · 2020
Product code MLO: Electrocardiograph, Ambulatory, With Analysis Algorithm
1 device under product code MLO, 2020, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Electrocardiograph, Ambulatory, With Analysis Algorithm. 21 CFR 870.2800, Class II. MAUDE held 24 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 |
|---|---|---|---|---|
| RX-1 Rhythm Express Remote Cardiac Monitoring SyK200833 · 510(k) | VivaQuant Inc. | Cardiovascular | database entry |
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