510(k) K934426

NERVE INTEGRITY MONITOR-2 (NIM-2 XL) by Xomed-Treace, Inc. — Product Code ETN

K934426 is an FDA 510(k) premarket notification submitted by Xomed-Treace, Inc. for the device "NERVE INTEGRITY MONITOR-2 (NIM-2 XL)". The FDA issued a decision of Substantially Equivalent on May 13, 1994. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Xomed-Treace, Inc. has at least 10 other 510(k) clearances on record.