510(k) K103142

SPACELABS MULTI-PARAMETER MODULE by Spacelabs Healthcare, Inc. — Product Code DSI

K103142 is an FDA 510(k) premarket notification submitted by Spacelabs Healthcare, Inc. for the device "SPACELABS MULTI-PARAMETER MODULE". The FDA issued a decision of Substantially Equivalent on March 3, 2011. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Spacelabs Healthcare, Inc. has at least 10 other 510(k) clearances on record.