EEG MONITOR WITH BIS, MODEL A-2000


Device Classification Name

index-generating electroencephalograph software

510(k) Number K030267
Device Name EEG MONITOR WITH BIS, MODEL A-2000
Original Applicant
ASPECT MEDICAL SYSTEMS, INC.
141 needham st.
newton, 
MA 
02464

Original Contact christine vozella
Regulation Number 882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OMC   ORT  
Date Received 01/27/2003
Decision Date 01/15/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No