BIS EEG VISTA MONITOR SYSTEM AND BISX


Device Classification Name

index-generating electroencephalograph software

510(k) Number K072286
Device Name BIS EEG VISTA MONITOR SYSTEM AND BISX
Applicant
ASPECT MEDICAL SYSTEMS, INC.
1 upland road
norwood, 
MA 
02062

Applicant Contact vikram verma
Correspondent
ASPECT MEDICAL SYSTEMS, INC.
1 upland road
norwood, 
MA 
02062

Correspodent Contact vikram verma
Regulation Number 882.1400
Classification Product Code
OLW  
Subsequent Product Codes
OLT   OMC   ORT  
Date Received 08/16/2007
Decision Date 11/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No