510(k) K230612

Edwards Algorithm for Measurement of Blood Hemoglobin by Edwards Lifesciences, LLC — Product Code MUD

K230612 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Edwards Algorithm for Measurement of Blood Hemoglobin". The FDA issued a decision of Substantially Equivalent on November 17, 2023. The device falls under product code MUD (Oximeter, Tissue Saturation), a Class II device regulated under 21 CFR 870.2700. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.