LOCALISA CARDIAC NAVIGATION SYSTEM

Computer, Diagnostic, Programmable

MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES

The following data is part of a premarket notification filed by Medtronic Surgical Navigation Technologies with the FDA for Localisa Cardiac Navigation System.

Pre-market Notification Details

Device IDK002869
510k NumberK002869
Device Name:LOCALISA CARDIAC NAVIGATION SYSTEM
ClassificationComputer, Diagnostic, Programmable
Applicant MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 3850 VICTORIA ST. NORTH Shoreview,  MN  55126
ContactThomas Parker
CorrespondentThomas Parker
MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 3850 VICTORIA ST. NORTH Shoreview,  MN  55126
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-13
Decision Date2001-03-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169006878 K002869 000

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