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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 K231415
Device Name EnSite™ X EP System
Applicant
Abbott Medical
One St. Jude Medical Dr.
St. Paul,  MN  55117
Applicant Contact Alyssa Timmers
Correspondent
Abbott Medical
One St. Jude Medical Dr.
St. Paul,  MN  55117
Correspondent Contact Alyssa Timmers
Regulation Number870.1425
Classification Product Code
DQK  
Date Received05/16/2023
Decision Date 08/10/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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