510(k) K053358

DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES by Ad-Tech Medical Instrument Corp — Product Code GZL

K053358 is an FDA 510(k) premarket notification submitted by Ad-Tech Medical Instrument Corp for the device "DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES". The FDA issued a decision of Substantially Equivalent on May 25, 2006. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Ad-Tech Medical Instrument Corp has at least 10 other 510(k) clearances on record.