510(k) K161164

CareEvent inclusive of the CareEvent Mobile Application accessory by Philips Medical Systems — Product Code MSX

K161164 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "CareEvent inclusive of the CareEvent Mobile Application accessory". The FDA issued a decision of Substantially Equivalent on June 24, 2016. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Philips Medical Systems has at least 10 other 510(k) clearances on record.