ECVUE MAPPING SYSTEM

Computer, Diagnostic, Programmable

CARDIOINSIGHT TECHNOLOGIES, INC

The following data is part of a premarket notification filed by Cardioinsight Technologies, Inc with the FDA for Ecvue Mapping System.

Pre-market Notification Details

Device IDK140497
510k NumberK140497
Device Name:ECVUE MAPPING SYSTEM
ClassificationComputer, Diagnostic, Programmable
Applicant CARDIOINSIGHT TECHNOLOGIES, INC 11000 CEDAR AVE SUITE 210 Cleveland,  OH  44106
ContactChristina V Vacca
CorrespondentChristina V Vacca
CARDIOINSIGHT TECHNOLOGIES, INC 11000 CEDAR AVE SUITE 210 Cleveland,  OH  44106
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-27
Decision Date2014-11-19
Summary:summary

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