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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 K030073
Device Name VERMED A10021 RESTING EKG TAB ELECTRODE
Applicant
Vermont Medical, Inc.
Industrial Park
Bellows Falls,  VT  05101
Applicant Contact MARC FILLION
Correspondent
Vermont Medical, Inc.
Industrial Park
Bellows Falls,  VT  05101
Correspondent Contact MARC FILLION
Regulation Number870.2360
Classification Product Code
DRX  
Date Received01/08/2003
Decision Date 03/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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