CARTO RMT EP NAVIGATION SYSTEM V8

Catheter, Electrode Recording, Or Probe, Electrode Recording

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 V8.

Pre-market Notification Details

Device IDK060047
510k NumberK060047
Device Name:CARTO RMT EP NAVIGATION SYSTEM V8
ClassificationCatheter, Electrode Recording, Or Probe, Electrode Recording
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 CodeDRF  
CFR Regulation Number870.1220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-01-06
Decision Date2006-06-19
Summary:summary

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