510(k) K081233

T-STAT 303 ISCHEMIA MONITORING SYSTEM by Spectros Corporation — Product Code MUD

K081233 is an FDA 510(k) premarket notification submitted by Spectros Corporation for the device "T-STAT 303 ISCHEMIA MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 28, 2008. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Spectros Corporation has at least 2 other 510(k) clearances on record.