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 a medical device manufactured by Barco N.V.. It received FDA 510(k) clearance on 2017-03-14 under approval 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. It is manufactured by Barco N.V.. The 510(k) number is K161880.
When was NIVR58-T kit approved by the FDA?
NIVR58-T kit received FDA 510(k) clearance on 2017-03-14, under approval number K161880.
What company makes NIVR58-T kit?
NIVR58-T kit is manufactured by Barco N.V..
What is the FDA product code for NIVR58-T kit?
The FDA product code for NIVR58-T kit is DXJ.
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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.