510(k) K001359

DASH 3000/4000 PATIENT MONITOR by General Electric Medical Systems Information Techn — Product Code DSI

K001359 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "DASH 3000/4000 PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on July 18, 2000. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. General Electric Medical Systems Information Techn has at least 10 other 510(k) clearances on record.