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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 K905489
Device Name VER-MED A10017 UNIVERSAL ELECTRODE
Applicant
Vermont Medical, Inc.
Industrial Park
Bellows Falls,  VT  05101
Applicant Contact DAVID LOVELL
Correspondent
Vermont Medical, Inc.
Industrial Park
Bellows Falls,  VT  05101
Correspondent Contact DAVID LOVELL
Regulation Number870.2360
Classification Product Code
DRX  
Date Received12/07/1990
Decision Date 03/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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