510(k) K141156

SPACELABS HEALTHCARE TELEMETRY RECEIVER by Spacelabs Healthcare — Product Code MHX

K141156 is an FDA 510(k) premarket notification submitted by Spacelabs Healthcare for the device "SPACELABS HEALTHCARE TELEMETRY RECEIVER". The FDA issued a decision of Substantially Equivalent on September 9, 2014. 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 Healthcare has at least 10 other 510(k) clearances on record.