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FDA 510(k)

Nexxis OR, Nexxis

K-Number: K170537 · 2017-04-21

ApplicantBarco N.V.
Decision Date2017-04-21
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Nexxis OR, Nexxis is a medical device manufactured by Barco N.V.. It received FDA 510(k) clearance on 2017-04-21 under approval number K170537. 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?

Nexxis OR, Nexxis is a medical device that received FDA 510(k) clearance on 2017-04-21. It is manufactured by Barco N.V.. The 510(k) number is K170537.

When was Nexxis OR, Nexxis approved by the FDA?

Nexxis OR, Nexxis received FDA 510(k) clearance on 2017-04-21, under approval number K170537.

What company makes Nexxis OR, Nexxis?

Nexxis OR, Nexxis is manufactured by Barco N.V..

What is the FDA product code for Nexxis OR, Nexxis?

The FDA product code for Nexxis OR, Nexxis is DXJ.

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Official Source

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