510(k) K912775

SAPPHIRE 4ME EMG/EP SYSTEM by Medelec Intl. Corp. — Product Code GWF

K912775 is an FDA 510(k) premarket notification submitted by Medelec Intl. Corp. for the device "SAPPHIRE 4ME EMG/EP SYSTEM". The FDA issued a decision of Substantially Equivalent on November 8, 1991. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Medelec Intl. Corp. has at least 10 other 510(k) clearances on record.