510(k) K231892

Definium Pace Select by Ge Hualun Medical Systems Co. , Ltd. — Product Code KPR

K231892 is an FDA 510(k) premarket notification submitted by Ge Hualun Medical Systems Co. , Ltd. for the device "Definium Pace Select". The FDA issued a decision of Substantially Equivalent on September 12, 2023. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Ge Hualun Medical Systems Co. , Ltd. has at least 10 other 510(k) clearances on record.