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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 K844099
Device Name CANMED 102
Applicant
Medtronic Vascular
Andover Medical
23 Ballard Way
Lawrence,  MA  01843
Applicant Contact ED SHAUGHNESSY
Correspondent
Medtronic Vascular
Andover Medical
23 Ballard Way
Lawrence,  MA  01843
Correspondent Contact ED SHAUGHNESSY
Regulation Number870.2360
Classification Product Code
DRX  
Date Received10/23/1984
Decision Date 12/27/1984
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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