510(k) K201863

Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape by Somatex Medical Technologies GmbH — Product Code NEU

K201863 is an FDA 510(k) premarket notification submitted by Somatex Medical Technologies GmbH for the device "Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape". The FDA issued a decision of Substantially Equivalent on February 18, 2021. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Somatex Medical Technologies GmbH has at least 6 other 510(k) clearances on record.