510(k) K082045

MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 by Spacelabs Medical, Inc. — Product Code MHX

K082045 is an FDA 510(k) premarket notification submitted by Spacelabs Medical, Inc. for the device "MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220". The FDA issued a decision of Substantially Equivalent on August 1, 2008. 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.