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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K050248
Device Name ELECTRODE
Applicant
Electramold
3600 Chamberlain Ln.
Suite 356
Louisville,  KY  40241
Applicant Contact E.W. JOHNSON
Correspondent
Electramold
3600 Chamberlain Ln.
Suite 356
Louisville,  KY  40241
Correspondent Contact E.W. JOHNSON
Regulation Number870.2360
Classification Product Code
DRX  
Date Received02/03/2005
Decision Date 05/25/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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