510(k) K152407

Infinity Delta, Infinity Delta XL, Infinity Kappa by Draeger Medical Sytems, Inc. — Product Code MHX

K152407 is an FDA 510(k) premarket notification submitted by Draeger Medical Sytems, Inc. for the device "Infinity Delta, Infinity Delta XL, Infinity Kappa". The FDA issued a decision of Substantially Equivalent on September 23, 2015. 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. Draeger Medical Sytems, Inc. has at least 1 other 510(k) clearance on record.