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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory, With Analysis Algorithm
510(k) Number K040753
Device Name R-TEST EVOLUTION 3
Applicant
Novacor
4, Passage Saint-Antoine
Rueil Malmaison Cedex,  FR 92508
Applicant Contact DOMINIQUE GRENIER
Correspondent
Novacor
4, Passage Saint-Antoine
Rueil Malmaison Cedex,  FR 92508
Correspondent Contact DOMINIQUE GRENIER
Regulation Number870.2800
Classification Product Code
MLO  
Date Received03/24/2004
Decision Date 06/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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