510(k) K220871

Nautilus by Dornier Medtech America, Inc. — Product Code JAA

K220871 is an FDA 510(k) premarket notification submitted by Dornier Medtech America, Inc. for the device "Nautilus". The FDA issued a decision of Substantially Equivalent on April 18, 2022. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Dornier Medtech America, Inc. has at least 10 other 510(k) clearances on record.