ENSITE VELOCITY SYSTEM

Computer, Diagnostic, Programmable

ST. JUDE MEDICAL

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Ensite Velocity System.

Pre-market Notification Details

Device IDK130727
510k NumberK130727
Device Name:ENSITE VELOCITY SYSTEM
ClassificationComputer, Diagnostic, Programmable
Applicant ST. JUDE MEDICAL One St. Jude Medical Drive St. Paul,  MN  55117
ContactDonna R Lunak
CorrespondentDonna R Lunak
ST. JUDE MEDICAL One St. Jude Medical Drive St. Paul,  MN  55117
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-18
Decision Date2013-08-29
Summary:summary

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