CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)

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 3 Navigation System (model:fg-5400-00), Carto 3 External Reference Patches (model:d-1283-01).

Pre-market Notification Details

Device IDK072202
510k NumberK072202
Device Name:CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE PATCHES (MODEL:D-1283-01)
ClassificationComputer, Diagnostic, Programmable
Applicant BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar,  CA  91765
ContactNatalie Bennington
CorrespondentNatalie Bennington
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 Received2007-08-08
Decision Date2007-11-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10846835000870 K072202 000

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