510(k) K040684

T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 by Spectros Corporation — Product Code MUD

K040684 is an FDA 510(k) premarket notification submitted by Spectros Corporation for the device "T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303". The FDA issued a decision of Substantially Equivalent on November 5, 2004. 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.