510(k) K221544

MagVenture TMS Atlas Neuro Navigation System by Tonica Elektronik A/S — Product Code HAW

K221544 is an FDA 510(k) premarket notification submitted by Tonica Elektronik A/S for the device "MagVenture TMS Atlas Neuro Navigation System". The FDA issued a decision of Substantially Equivalent on March 17, 2023. The device falls under product code HAW (Neurological Stereotaxic Instrument), a Class II device regulated under 21 CFR 882.4560. Tonica Elektronik A/S has at least 10 other 510(k) clearances on record.