510(k) K101619

WELCH ALLYN 1500 PATIENT MONITOR by Schiller AG — Product Code MHX

K101619 is an FDA 510(k) premarket notification submitted by Schiller AG for the device "WELCH ALLYN 1500 PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on November 12, 2010. 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. Schiller AG has at least 10 other 510(k) clearances on record.