510(k) K801671

ESG-1 (EVOKED RESPONSE STIMULUS GENER) by Neurodiagnostics, Inc. — Product Code GWE

K801671 is an FDA 510(k) premarket notification submitted by Neurodiagnostics, Inc. for the device "ESG-1 (EVOKED RESPONSE STIMULUS GENER)". The FDA issued a decision of Substantially Equivalent on August 4, 1980. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Neurodiagnostics, Inc. has at least 3 other 510(k) clearances on record.