510(k) K212003

ESSENZ Patient Monitor by Livanova Deutschland, GmbH — Product Code DXJ

K212003 is an FDA 510(k) premarket notification submitted by Livanova Deutschland, GmbH for the device "ESSENZ Patient Monitor". The FDA issued a decision of Substantially Equivalent on November 10, 2021. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. Livanova Deutschland, GmbH has at least 6 other 510(k) clearances on record.