510(k) K030613

VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 by Criticare Systems, Inc. — Product Code MHX

K030613 is an FDA 510(k) premarket notification submitted by Criticare Systems, Inc. for the device "VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100". The FDA issued a decision of Substantially Equivalent on April 17, 2003. 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. Criticare Systems, Inc. has at least 10 other 510(k) clearances on record.