510(k) K133994

SIVR56-T KIT by Barco N.V. — Product Code DXJ

K133994 is an FDA 510(k) premarket notification submitted by Barco N.V. for the device "SIVR56-T KIT". The FDA issued a decision of Substantially Equivalent on December 1, 2014. 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.