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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 K854924
Device Name AMI E-Z-PACE ELECTODE
Applicant
A.M.I. Corp.
23 Ballard Way
Lawrence,  MA  01843
Applicant Contact THOMAS
Correspondent
A.M.I. Corp.
23 Ballard Way
Lawrence,  MA  01843
Correspondent Contact THOMAS
Regulation Number870.5550
Classification Product Code
DRO  
Date Received12/10/1985
Decision Date 02/26/1986
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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