510(k) K102422

SPACELABS MEDICAL PATIENT MONITORS by Spacelabs Medical, Inc. — Product Code MHX

K102422 is an FDA 510(k) premarket notification submitted by Spacelabs Medical, Inc. for the device "SPACELABS MEDICAL PATIENT MONITORS". The FDA issued a decision of Substantially Equivalent on December 7, 2010. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Spacelabs Medical, Inc. has at least 10 other 510(k) clearances on record.