MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000

Computer, Diagnostic, Programmable

ST. JUDE MEDICAL

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Modification To: Ensite System, Model, Ee3000.

Pre-market Notification Details

Device IDK070902
510k NumberK070902
Device Name:MODIFICATION TO: ENSITE SYSTEM, MODEL, EE3000
ClassificationComputer, Diagnostic, Programmable
Applicant ST. JUDE MEDICAL 1350 ENERGY LN., SUITE 110 St. Paul,  MN  55108
ContactKaren J Mckelvey
CorrespondentKaren J Mckelvey
ST. JUDE MEDICAL 1350 ENERGY LN., SUITE 110 St. Paul,  MN  55108
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-02
Decision Date2007-05-01
Summary:summary

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