510(k) K851190

NYSTAGMOGRAPH EOG/ENG ANALYSES by Nicolet Biomedical Instruments — Product Code GWN

K851190 is an FDA 510(k) premarket notification submitted by Nicolet Biomedical Instruments for the device "NYSTAGMOGRAPH EOG/ENG ANALYSES". The FDA issued a decision of Substantially Equivalent on November 27, 1985. The device falls under product code GWN (Nystagmograph), a Class II device regulated under 21 CFR 882.1460. Nicolet Biomedical Instruments has at least 10 other 510(k) clearances on record.