510(k) K012171

MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS by Visicu, Inc. — Product Code MSX

K012171 is an FDA 510(k) premarket notification submitted by Visicu, Inc. for the device "MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS". The FDA issued a decision of Substantially Equivalent on July 24, 2001. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. Visicu, Inc. has at least 6 other 510(k) clearances on record.