510(k) K182417

ROSA ONE Brain Application by Medtech S.A — Product Code HAW

K182417 is an FDA 510(k) premarket notification submitted by Medtech S.A for the device "ROSA ONE Brain Application". The FDA issued a decision of Substantially Equivalent on February 7, 2019. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Medtech S.A has at least 10 other 510(k) clearances on record.