510(k) K001980

ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110 by Aspect Medical Systems, Inc. — Product Code GXY

K001980 is an FDA 510(k) premarket notification submitted by Aspect Medical Systems, Inc. for the device "ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110". The FDA issued a decision of Substantially Equivalent on September 27, 2000. 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.