510(k) K062692

BIS BILATERAL SENSOR by Aspect Medical Systems, Inc. — Product Code GXY

K062692 is an FDA 510(k) premarket notification submitted by Aspect Medical Systems, Inc. for the device "BIS BILATERAL SENSOR". The FDA issued a decision of Substantially Equivalent on December 13, 2006. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Aspect Medical Systems, Inc. has at least 10 other 510(k) clearances on record.