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510(k) K141050

ENSITE VELOCITY SYSTEM by St Jude Medical — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2014
Date Received
April 23, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

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