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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K112319
Device Name ELECTRO-CAP SYSTEM
Applicant
Electro-Cap Intl., Inc.
1011 W. Lexington Rd.
Eaton,  OH  45320
Applicant Contact AMY B SWALLOWS
Correspondent
Electro-Cap Intl., Inc.
1011 W. Lexington Rd.
Eaton,  OH  45320
Correspondent Contact AMY B SWALLOWS
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/11/2011
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
Predetermined Change
Control Plan Authorized		 No
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