510(k) K110138

PAIRED HYDROGEL ELECTRODE by Neurovision Medical Products, Inc. — Product Code ETN

K110138 is an FDA 510(k) premarket notification submitted by Neurovision Medical Products, Inc. for the device "PAIRED HYDROGEL ELECTRODE". The FDA issued a decision of Substantially Equivalent on April 8, 2011. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Neurovision Medical Products, Inc. has at least 8 other 510(k) clearances on record.