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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 the device name listed in this FDA 510(k) record. The listed applicant is Finapres Medical Systems B.V.. It received FDA 510(k) clearance on 2018-11-06 under 510(k) 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. The listed applicant is Finapres Medical Systems B.V.. The 510(k) number is K173916.

When did Finapres Nova Noninvasive Hemodynamic Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for Finapres Nova Noninvasive Hemodynamic Monitor?

The FDA 510(k) record lists Finapres Medical Systems B.V. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Finapres Medical Systems B.V. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160967Finapres Nova Noninvasive Hemodynamic Monitor

Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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