SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY


Device Classification Name

electrode, cutaneous

510(k) Number K022197
Device Name SURFACE ELECTRODE FOR ELECTROENCEPHALOGRAPHY
Original Applicant
THE ELECTRIC STORE
936-11th avenue east
seattle, 
WA 
98102

Original Contact carl youngmann
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 07/05/2002
Decision Date 08/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No