EEG MIS MONITOR MODEL # A-2000; BIS ENGINE


Device Classification Name

index-generating electroencephalograph software

510(k) Number K011534
Device Name EEG MIS MONITOR MODEL # A-2000; BIS ENGINE
Original Applicant
ASPECT MEDICAL SYSTEMS, INC.
141 needham st.
newton, 
MA 
02464

Original Contact christine m vozella
Regulation Number 882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OLT   OMC   ORT  
Date Received 05/18/2001
Decision Date 06/15/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Special
Reviewed by Third Party No

Combination Product

No