CardioInsight Cardiac 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 Cardioinsight Cardiac Mapping System.

Pre-market Notification Details

Device IDK162440
510k NumberK162440
Device Name:CardioInsight Cardiac Mapping System
ClassificationComputer, Diagnostic, Programmable
Applicant CARDIOINSIGHT TECHNOLOGIES, INC 11000 CEDAR AVE SUITE 210 Cleveland,  OH  44106
ContactLaurie Lewandowski
CorrespondentLaurie Lewandowski
MEDTRONIC (OWNER/OPERATOR) 8200 CORAL SEA ST NE Mounds View,  MN  55112
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-08-31
Decision Date2016-11-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169723689 K162440 000
00643169723672 K162440 000
00643169723665 K162440 000
00643169723658 K162440 000
00643169723603 K162440 000
00763000045456 K162440 000
00763000045449 K162440 000
00763000045432 K162440 000
00763000045425 K162440 000

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