3 devices · 3 companies · 2023 to 2025
Product code QUO: Adjunctive Heart Failure Status Indicator
3 devices under product code QUO, 2023 to 2025, from 3 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Adjunctive Heart Failure Status Indicator. 21 CFR 870.2200, Class II. The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy. MAUDE held 0 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 |
|---|---|---|---|---|
| CardioVisionK251293 · 510(k) | Icardio.Ai | Cardiovascular | database entry | |
| EchoGo Heart FailureK240013 · 510(k) | Ultromics Limited | Cardiovascular | database entry | |
| Vivio LVEDP SystemK223905 · 510(k) | Avicena, LLC | Cardiovascular | database entry |
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