510(k) K242678

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

K242678 is an FDA 510(k) premarket notification submitted by Ge Hualun Medical Systems Co. , Ltd. for the device "Definium Pace Select ET". The FDA issued a decision of Substantially Equivalent on October 1, 2024. 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.