510(k) K011093

AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 by Agilent Technologies, Inc. — Product Code MHX

K011093 is an FDA 510(k) premarket notification submitted by Agilent Technologies, Inc. for the device "AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154". The FDA issued a decision of Substantially Equivalent on May 1, 2001. 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. Agilent Technologies, Inc. has at least 10 other 510(k) clearances on record.