510(k) K062098

SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX by Datascope Corp. — Product Code MHX

K062098 is an FDA 510(k) premarket notification submitted by Datascope Corp. for the device "SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX". The FDA issued a decision of Substantially Equivalent on February 5, 2007. 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. Datascope Corp. has at least 10 other 510(k) clearances on record.