510(k) K161880

NIVR58-T kit by Barco N.V. — Product Code DXJ

K161880 is an FDA 510(k) premarket notification submitted by Barco N.V. for the device "NIVR58-T kit". The FDA issued a decision of Substantially Equivalent on March 14, 2017. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Barco N.V. has at least 10 other 510(k) clearances on record.