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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 K841944
Device Name DISPOSABLE ECG ELECTRODE
Applicant
Bristol Medical Electronics Corp.
P.O. Box 809
Mansfield,  MA  02048 -
Applicant Contact MICHAEL R DUPELLE
Correspondent
Bristol Medical Electronics Corp.
P.O. Box 809
Mansfield,  MA  02048 -
Correspondent Contact MICHAEL R DUPELLE
Regulation Number870.2360
Classification Product Code
DRX  
Date Received05/11/1984
Decision Date 03/01/1985
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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