510(k) K830579

MULTI-SIGNAL AUDITORY STIMULATOR SM700 by Nicolet Biomedical Instruments — Product Code GWJ

K830579 is an FDA 510(k) premarket notification submitted by Nicolet Biomedical Instruments for the device "MULTI-SIGNAL AUDITORY STIMULATOR SM700". The FDA issued a decision of Substantially Equivalent on March 8, 1983. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Nicolet Biomedical Instruments has at least 10 other 510(k) clearances on record.