510(k) K183387

M3290B Patient Information Center iX by Philips Medical Systems — Product Code MHX

K183387 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "M3290B Patient Information Center iX". The FDA issued a decision of Substantially Equivalent on August 6, 2019. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Philips Medical Systems has at least 10 other 510(k) clearances on record.