510(k) K230320

NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube by Medtronic Xomed, Inc. — Product Code ETN

K230320 is an FDA 510(k) premarket notification submitted by Medtronic Xomed, Inc. for the device "NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube". The FDA issued a decision of Substantially Equivalent on October 26, 2023. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Medtronic Xomed, Inc. has at least 10 other 510(k) clearances on record.