REUSABLE STIMULATING ELECTRODES


Device Classification Name

electrode, cutaneous

510(k) Number K111270
Device Name REUSABLE STIMULATING ELECTRODES
Applicant
BIO PROTECH, INC.
3010 lbj frwy.
12th floor
dallas, 
TX 
75234

Applicant Contact judy burton
Correspondent
BIO PROTECH, INC.
3010 lbj frwy.
12th floor
dallas, 
TX 
75234

Correspodent Contact judy burton
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 05/03/2011
Decision Date 09/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No