510(k) K233750

ECG-less Cardiac by Ge Medical Systems, LLC — Product Code JAK

K233750 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "ECG-less Cardiac". The FDA issued a decision of Substantially Equivalent on April 2, 2024. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Ge Medical Systems, LLC has at least 10 other 510(k) clearances on record.