510(k) K021097

QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52 by Spacelabs Medical, Inc. — Product Code DSI

K021097 is an FDA 510(k) premarket notification submitted by Spacelabs Medical, Inc. for the device "QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52". The FDA issued a decision of Substantially Equivalent on June 28, 2002. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Spacelabs Medical, Inc. has at least 10 other 510(k) clearances on record.