CARTO XP EP NAVIGATION SYSTEM, VERSION 10

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 Xp Ep Navigation System, Version 10.

Pre-market Notification Details

Device IDK093566
510k NumberK093566
Device Name:CARTO XP EP NAVIGATION SYSTEM, VERSION 10
ClassificationComputer, Diagnostic, Programmable
Applicant BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar,  CA  91765
ContactWayne R Hohman
CorrespondentWayne R Hohman
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 Received2009-11-18
Decision Date2010-06-18
Summary:summary

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