510(k) K151366

Philips CS770 IntelliSpace Critical Care and Anesthesia by Philips Medical Systems — Product Code DXJ

K151366 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "Philips CS770 IntelliSpace Critical Care and Anesthesia". The FDA issued a decision of Substantially Equivalent on October 30, 2015. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Philips Medical Systems has at least 10 other 510(k) clearances on record.