CARTO RMT EP NAVIGATION SYSTEM

Computer, Diagnostic, Programmable

BIOSENSE WEBSTER, INC.

The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Carto Rmt Ep Navigation System.

Pre-market Notification Details

Device IDK042681
510k NumberK042681
Device Name:CARTO RMT EP NAVIGATION SYSTEM
ClassificationComputer, Diagnostic, Programmable
Applicant BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar,  CA  91765
ContactDiana Thorson
CorrespondentDiana Thorson
BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar,  CA  91765
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-29
Decision Date2005-09-29
Summary:summary

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