ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106


Device Classification Name

electrode, cutaneous

510(k) Number K002734
Device Name ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106
Original Applicant
ASPECT MEDICAL SYSTEMS, INC.
141 needham st.
newton, 
MA 
02464

Original Contact christine m vozella
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 09/01/2000
Decision Date 09/14/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Special
Reviewed by Third Party No

Combination Product

No