510(k) K221903

Delta III Pro by Dornier Medtech America, Inc. — Product Code LNS

K221903 is an FDA 510(k) premarket notification submitted by Dornier Medtech America, Inc. for the device "Delta III Pro". The FDA issued a decision of Substantially Equivalent on February 22, 2023. The device falls under product code LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological), a Class II device regulated under 21 CFR 876.5990. Dornier Medtech America, Inc. has at least 10 other 510(k) clearances on record.