510(k) K071805

NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX by Datascope Corp. — Product Code DSI

K071805 is an FDA 510(k) premarket notification submitted by Datascope Corp. for the device "NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX". The FDA issued a decision of Substantially Equivalent on September 25, 2007. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Datascope Corp. has at least 10 other 510(k) clearances on record.