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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 K183128
Device Name EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2
Applicant
Abbott
One St. Jude Medical Dr.
St. Paul,  MN  55117
Applicant Contact Cody Johnson
Correspondent
Abbott
One St. Jude Medical Dr.
St. Paul,  MN  55117
Correspondent Contact Cody Johnson
Regulation Number870.1425
Classification Product Code
DQK  
Date Received11/13/2018
Decision Date 12/12/2018
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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