510(k) K920264

BIO-DETEK TRACERITE EEG ELECTRODE by Bio-Detek, Inc. — Product Code GXY

K920264 is an FDA 510(k) premarket notification submitted by Bio-Detek, Inc. for the device "BIO-DETEK TRACERITE EEG ELECTRODE". The FDA issued a decision of Substantially Equivalent on June 2, 1992. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Bio-Detek, Inc. has at least 10 other 510(k) clearances on record.