510(k) K062278

SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847 by Spacelabs Medical, Inc. — Product Code MSX

K062278 is an FDA 510(k) premarket notification submitted by Spacelabs Medical, Inc. for the device "SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847". The FDA issued a decision of Substantially Equivalent on September 19, 2006. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Spacelabs Medical, Inc. has at least 10 other 510(k) clearances on record.