510(k) K972502

SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496 by Spacelabs Medical, Inc. — Product Code DSI

K972502 is an FDA 510(k) premarket notification submitted by Spacelabs Medical, Inc. for the device "SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496". The FDA issued a decision of Substantially Equivalent on May 28, 1998. 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.