510(k) K022740

DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE by Datex-Ohmeda — Product Code MLD

K022740 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda for the device "DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE". The FDA issued a decision of Substantially Equivalent on November 14, 2002. The device falls under product code MLD (Monitor, St Segment With Alarm), a Class II device regulated under 21 CFR 870.1025. Datex-Ohmeda has at least 10 other 510(k) clearances on record.