510(k) K150313

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

K150313 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 July 9, 2015. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Neuwave Medical, Inc. has at least 10 other 510(k) clearances on record.