510(k) K061960

FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 by Cas Medical Systems, Inc. — Product Code MUD

K061960 is an FDA 510(k) premarket notification submitted by Cas Medical Systems, Inc. for the device "FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040". The FDA issued a decision of Substantially Equivalent on September 5, 2006. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Cas Medical Systems, Inc. has at least 10 other 510(k) clearances on record.