510(k) K230919

Acumen IQ finger cuff by Edwards Lifesciences, LLC — Product Code DXN

K230919 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "Acumen IQ finger cuff". The FDA issued a decision of Substantially Equivalent on October 24, 2023. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.