3 devices · 1 company · 2021 to 2022
Product code QNV: Adjunctive Hemodynamic Indicator With Decision Point
3 devices under product code QNV, 2021 to 2022, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 3 here), the regulation, and MAUDE report counts by product code.
Adjunctive Hemodynamic Indicator With Decision Point. 21 CFR 870.2220, Class II. An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information. 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.
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| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| AHI SystemK221203 · 510(k) | Fifth Eye Inc. | Cardiovascular | database entry | |
| AHI SystemK212219 · 510(k) | Fifth Eye Inc. | Cardiovascular | database entry | |
| Analytic for Hemodynamic InstabilityDEN200022 · De Novo | Fifth Eye Inc. | Cardiovascular | database entry |
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