510(k) K000963

DA VINCHI EEG AND EMG/EP SYSTEMS by Airsep Corp. — Product Code GWF

K000963 is an FDA 510(k) premarket notification submitted by Airsep Corp. for the device "DA VINCHI EEG AND EMG/EP SYSTEMS". The FDA issued a decision of Substantially Equivalent on October 20, 2000. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Airsep Corp. has at least 10 other 510(k) clearances on record.