510(k) K960732

HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500 by Physiometrix, Inc. — Product Code GXY

K960732 is an FDA 510(k) premarket notification submitted by Physiometrix, Inc. for the device "HYDROSPOT EEG ELECTRODE MODEL 1501, HYDROSPOT LEADWIRE MODEL 1500". The FDA issued a decision of Substantially Equivalent on April 15, 1996. 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.