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FDA 510(k)

NIVR58-T kit

K-Number: K161880 · 2017-03-14

ApplicantBarco N.V.
Decision Date2017-03-14
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NIVR58-T kit is the device name listed in this FDA 510(k) record. The listed applicant is Barco N.V.. It received FDA 510(k) clearance on 2017-03-14 under 510(k) number K161880. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIVR58-T kit?

NIVR58-T kit is a medical device that received FDA 510(k) clearance on 2017-03-14. The listed applicant is Barco N.V.. The 510(k) number is K161880.

When did NIVR58-T kit receive FDA 510(k) clearance?

NIVR58-T kit received FDA 510(k) clearance on 2017-03-14, under 510(k) number K161880.

Who is the listed applicant for NIVR58-T kit?

The FDA 510(k) record lists Barco N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIVR58-T kit?

The FDA product code for NIVR58-T kit is DXJ.

Other records listing Barco N.V. as applicant

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Related Devices (Code: DXJ)

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.

K212003ESSENZ Patient MonitorLivanova Deutschland, GmbHK212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbHK201162Essence 55SP Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc.K180534Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbHK173381Nexxis ORBarco N.V.

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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