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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
510(k) Number K862298
Device Name ALTERNATE SIZE E-Z-PACE ELECTRODE
Applicant
Medtronic Vascular
Andover Medical
23 Ballard Way
Lawrence,  MA  01843
Applicant Contact THOMAS
Correspondent
Medtronic Vascular
Andover Medical
23 Ballard Way
Lawrence,  MA  01843
Correspondent Contact THOMAS
Regulation Number870.5550
Classification Product Code
DRO  
Date Received06/17/1986
Decision Date 07/11/1986
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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