BRAINET


Device Classification Name

electrode, cutaneous

510(k) Number K021986
Device Name BRAINET
Original Applicant
NICOLET BIOMEDICAL, INC.
800 levanger ln.
stoughton, 
WI 
53589

Original Contact gary syring
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 06/18/2002
Decision Date 08/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No