510(k) K841497

NEUROPACK 8 MEE 4108 by Nihon Kohden America, Inc. — Product Code GWK

K841497 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "NEUROPACK 8 MEE 4108". The FDA issued a decision of Substantially Equivalent on June 7, 1984. The device falls under product code GWK (Conditioner, Signal, Physiological), a Class II device regulated under 21 CFR 882.1845. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.