510(k) K192427

Ablation Confirmation by Neuwave Medical, Inc. — Product Code JAK

K192427 is an FDA 510(k) premarket notification submitted by Neuwave Medical, Inc. for the device "Ablation Confirmation". The FDA issued a decision of Substantially Equivalent on October 3, 2019. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Neuwave Medical, Inc. has at least 10 other 510(k) clearances on record.