510(k) K112686

NEXT GEN EMG ENDOTRACHEAL TUBE by Medtronic Xomed, Inc. — Product Code ETN

K112686 is an FDA 510(k) premarket notification submitted by Medtronic Xomed, Inc. for the device "NEXT GEN EMG ENDOTRACHEAL TUBE". The FDA issued a decision of Substantially Equivalent on June 27, 2012. 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.