510(k) K240403

Access BR Monitor by Beckman Coulter, Inc. — Product Code MOI

K240403 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access BR Monitor". The FDA issued a decision of Substantially Equivalent on May 9, 2024. The device falls under product code MOI (System, Test, Immunological, Antigen, Tumor), a Class II device regulated under 21 CFR 866.6010. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.