510(k) K181311

Philips Hemodynamic Application R1.0 by Philips Medical Systems Nederlands B.V. — Product Code MWI

K181311 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederlands B.V. for the device "Philips Hemodynamic Application R1.0". The FDA issued a decision of Substantially Equivalent on September 7, 2018. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Philips Medical Systems Nederlands B.V. has at least 7 other 510(k) clearances on record.