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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, diagnostic, programmable
510(k) Number K132073
Device Name EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE
Applicant
ST. JUDE MEDICAL
One St. Jude Medical Drive
St. Paul,  MN  55117
Applicant Contact KRIS MILLER
Correspondent
ST. JUDE MEDICAL
One St. Jude Medical Drive
St. Paul,  MN  55117
Correspondent Contact KRIS MILLER
Regulation Number870.1425
Classification Product Code
DQK  
Date Received07/03/2013
Decision Date 09/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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