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FDA 510(k)

Nexxis OR

K-Number: K173381 · 2018-02-22

ApplicantBarco N.V.
Decision Date2018-02-22
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Nexxis OR 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 2018-02-22 under 510(k) number K173381. 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 Nexxis OR?

Nexxis OR is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is Barco N.V.. The 510(k) number is K173381.

When did Nexxis OR receive FDA 510(k) clearance?

Nexxis OR received FDA 510(k) clearance on 2018-02-22, under 510(k) number K173381.

Who is the listed applicant for Nexxis OR?

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 Nexxis OR?

The FDA product code for Nexxis OR 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 GmbHK172969Essence 55S Large Monitor SystemShenyang Torch-Bigtide Digital Technology Co., Ltd.

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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