ELECTRO-CAP SYSTEM


Device Classification Name

electrode, cutaneous

510(k) Number K112319
Device Name ELECTRO-CAP SYSTEM
Applicant
ELECTRO-CAP INTL., INC.
1011 west lexington rd.
eaton, 
OH 
45320

Applicant Contact amy b swallows
Correspondent
ELECTRO-CAP INTL., INC.
1011 west lexington rd.
eaton, 
OH 
45320

Correspodent Contact amy b swallows
Regulation Number 882.1320
Classification Product Code
GXY  
Date Received 08/11/2011
Decision Date 01/27/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No