510(k) K020670

MODEL 4310 PSARRAY2 EEG ELECTRODE by Physiometrix, Inc. — Product Code GXY

K020670 is an FDA 510(k) premarket notification submitted by Physiometrix, Inc. for the device "MODEL 4310 PSARRAY2 EEG ELECTRODE". The FDA issued a decision of Substantially Equivalent on October 8, 2002. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Physiometrix, Inc. has at least 10 other 510(k) clearances on record.