510(k) K012837

MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES by Datex-Ohmeda — Product Code MLD

K012837 is an FDA 510(k) premarket notification submitted by Datex-Ohmeda for the device "MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on September 14, 2001. 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.