510(k) K182245

EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System by Edwards Lifesciences, LLC — Product Code DXN

K182245 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System". The FDA issued a decision of Substantially Equivalent on Nov 30, 2018. 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 157 other 510(k) clearances on record.