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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Pacemaker Generator Function
510(k) Number K850077
Device Name MEDTRONIC 5311 PACING SYSTEM ANALYZER
Applicant
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Applicant Contact MARTIN E KIENITZ
Correspondent
Medtronic Vascular
800 53rd Ave., NE
P.O. Box 1250
Minneapolis,  MN  55440
Correspondent Contact MARTIN E KIENITZ
Regulation Number870.3630
Classification Product Code
DTC  
Date Received01/09/1985
Decision Date 07/16/1985
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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