510(k) K242304

RED by Neuraxis, Inc. — Product Code KLA

K242304 is an FDA 510(k) premarket notification submitted by Neuraxis, Inc. for the device "RED". The FDA issued a decision of Substantially Equivalent on December 6, 2024. The device falls under product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube), a Class II device regulated under 21 CFR 876.1725. Neuraxis, Inc. has at least 3 other 510(k) clearances on record.