Finapres Nova Noninvasive Hemodynamic Monitor
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- NOVA EUDAMED
- Device Name
- Finapres NOVA EUDAMED
- Model / Reference
- FP_N03.28X EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-FP_N03.28XCK EUDAMED
- Basic UDI-DI
- B-FP_N03.28XCK EUDAMED
- 510(k) Number
- K173916 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)
- Market of Registration
- Poland EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The Finapres Nova Noninvasive Hemodynamic Monitor is a device classified as a non-invasive blood pressure monitor (Device Type: DXN) that measures arterial blood pressure and hemodynamic parameters without penetrating the skin. It employs photoplethysmography and volume-clamp technology to continuously track systolic, diastolic, and mean arterial pressure, as well as heart rate and pulse wave analysis in real time.
This device is intended for use in clinical settings, including intensive care units and cardiovascular monitoring environments, where continuous hemodynamic assessment is required. Supplied as a reusable system, it requires proper calibration and maintenance per manufacturer instructions. Authorized under FDA 510K clearance and MDD compliance, the Finapres Nova adheres to regulatory standards for non-invasive hemodynamic monitoring, ensuring accuracy and reliability for patient care.
Frequently asked questions
What types of clinical environments is the Finapres Nova Noninvasive Hemodynamic Monitor designed for, and why?
The Finapres Nova is specifically designed for clinical settings where continuous hemodynamic monitoring is critical, such as intensive care units (ICUs) and cardiovascular monitoring environments. This is because it uses non-invasive photoplethysmography and volume-clamp technology to provide real-time measurements of systolic, diastolic, and mean arterial pressure, as well as heart rate and pulse wave analysis—key parameters for patients requiring close cardiovascular oversight.
How is the Finapres Nova Noninvasive Hemodynamic Monitor supplied, and what does this mean for its maintenance?
The Finapres Nova is supplied as a reusable system, meaning it is not single-use. This implies that it requires proper calibration, cleaning, and maintenance as outlined in the manufacturer’s instructions to ensure accuracy and reliability over repeated use. Regular upkeep is essential to maintain performance standards for continuous hemodynamic monitoring.
What regulatory pathways has the Finapres Nova Noninvasive Hemodynamic Monitor followed, and what does this indicate about its compliance?
The Finapres Nova has undergone FDA 510K clearance and complies with the Medical Device Directive (MDD). The FDA’s 510K process confirms that the device is substantially equivalent to a legally marketed predicate device, while MDD compliance ensures it meets European Union safety, performance, and quality standards for non-invasive hemodynamic monitors. This dual authorization reflects rigorous regulatory scrutiny for clinical-grade monitoring devices.
What specific hemodynamic parameters does the Finapres Nova measure, and why is continuous monitoring important in its intended use?
The Finapres Nova measures systolic, diastolic, and mean arterial pressure in real time, along with heart rate and pulse wave analysis. Continuous monitoring of these parameters is vital in critical care settings because it allows clinicians to promptly assess cardiovascular stability, detect early signs of hemodynamic instability, and adjust treatments accordingly—reducing risks associated with acute changes in blood pressure or heart function.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173916 | Class II | Active |
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Manufacturer
- Manufacturer
- Finapres Medical Systems B.V.
Sources (2)
- FDA 510(k) K173916 24 fields · synced Sep 18, 2026
- EUDAMED 7e19b624-0e80-499e-9e58-28238b686203 61 fields · synced Jul 12, 2026