510(k) K181025

I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System by Neuro Kinetics, Inc. — Product Code GWN

K181025 is an FDA 510(k) premarket notification submitted by Neuro Kinetics, Inc. for the device "I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Portal Video Oculography Eye Tracking System". The FDA issued a decision of Substantially Equivalent on July 24, 2018. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Neuro Kinetics, Inc. has at least 3 other 510(k) clearances on record.