510(k) K162012

CARESCAPE Central Station V2 by GE Healthcare — Product Code DXJ

K162012 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "CARESCAPE Central Station V2". The FDA issued a decision of Substantially Equivalent on September 15, 2016. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. GE Healthcare has at least 10 other 510(k) clearances on record.