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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 K160210
Device Name EnSite Precision Cardiac Mapping System v2.0
Applicant
ST. JUDE MEDICAL
One St. Jude Medical Dr
St. Paul,  MN  55117
Applicant Contact Marlene Peterson
Correspondent
ST. JUDE MEDICAL
One St. Jude Medical Dr
St. Paul,  MN  55117
Correspondent Contact Marlene Peterson
Regulation Number870.1425
Classification Product Code
DQK  
Date Received01/28/2016
Decision Date 12/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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