510(k) K093501

ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION by Spacelabs Medical, Inc. — Product Code MHX

K093501 is an FDA 510(k) premarket notification submitted by Spacelabs Medical, Inc. for the device "ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION". The FDA issued a decision of Substantially Equivalent on November 24, 2009. 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. Spacelabs Medical, Inc. has at least 10 other 510(k) clearances on record.