DISPOSABLE ELECTRODE


Device Classification Name

electrode, cutaneous

510(k) Number K111737
Device Name DISPOSABLE ELECTRODE
Applicant
SANIBEL SUPPLY
drejervaenget 8
assens, 

DK

dk-5610

Applicant Contact erik nielsen
Correspondent
SANIBEL SUPPLY
drejervaenget 8
assens, 

DK

dk-5610

Correspodent Contact erik nielsen
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 06/21/2011
Decision Date 10/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No