510(k) K801604

PATHFINDER ELECTRODIAGNOSTIC SYSTEM by Nicolet Biomedical Instruments — Product Code GWK

K801604 is an FDA 510(k) premarket notification submitted by Nicolet Biomedical Instruments for the device "PATHFINDER ELECTRODIAGNOSTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on August 4, 1980. The device falls under product code GWK (Conditioner, Signal, Physiological), a Class II device regulated under 21 CFR 882.1845. Nicolet Biomedical Instruments has at least 10 other 510(k) clearances on record.