510(k) K942196

3050 DIASCOPE NT PATIENT MONITOR by S & W Medico Teknik A/S — Product Code DSI

K942196 is an FDA 510(k) premarket notification submitted by S & W Medico Teknik A/S for the device "3050 DIASCOPE NT PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on June 28, 1995. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. S & W Medico Teknik A/S has at least 10 other 510(k) clearances on record.