510(k) K050605

SPACELABS MEDICAL MULTIPARAMETER MODULE 91496 by Spacelabs Medical, Inc. — Product Code DSI

K050605 is an FDA 510(k) premarket notification submitted by Spacelabs Medical, Inc. for the device "SPACELABS MEDICAL MULTIPARAMETER MODULE 91496". The FDA issued a decision of Substantially Equivalent on May 3, 2005. 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.