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FDA 510(k)

Finapres Nova Noninvasive Hemodynamic Monitor

K-Number: K173916 · 2018-11-06

ApplicantFinapres Medical Systems B.V.
Decision Date2018-11-06
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Finapres Nova Noninvasive Hemodynamic Monitor is a medical device manufactured by Finapres Medical Systems B.V.. It received FDA 510(k) clearance on 2018-11-06 under approval number K173916. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Finapres Nova Noninvasive Hemodynamic Monitor?

Finapres Nova Noninvasive Hemodynamic Monitor is a medical device that received FDA 510(k) clearance on 2018-11-06. It is manufactured by Finapres Medical Systems B.V.. The 510(k) number is K173916.

When was Finapres Nova Noninvasive Hemodynamic Monitor approved by the FDA?

Finapres Nova Noninvasive Hemodynamic Monitor received FDA 510(k) clearance on 2018-11-06, under approval number K173916.

What company makes Finapres Nova Noninvasive Hemodynamic Monitor?

Finapres Nova Noninvasive Hemodynamic Monitor is manufactured by Finapres Medical Systems B.V..

What is the FDA product code for Finapres Nova Noninvasive Hemodynamic Monitor?

The FDA product code for Finapres Nova Noninvasive Hemodynamic Monitor is DXN.

Related Clinical Trials

NCT07571473 CoreSys Monitoring for Intraoperative Stress Management in Abdominal Hysterectomy RECRUITING NCT07445659 qCON/qNOX-Guided Anesthesia in Patients Undergoing Thyroidectomy Surgery RECRUITING

Related PubMed Literature

PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025)

Other Devices by Finapres Medical Systems B.V.

K160967Finapres Nova Noninvasive Hemodynamic Monitor

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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