TruDi Navigation System

Ear, Nose, And Throat Stereotaxic Instrument

Biosense Webster

The following data is part of a premarket notification filed by Biosense Webster with the FDA for Trudi Navigation System.

Pre-market Notification Details

Device IDK192397
510k NumberK192397
Device Name:TruDi Navigation System
ClassificationEar, Nose, And Throat Stereotaxic Instrument
Applicant Biosense Webster 33 Technology Drive Irvine,  CA  92618
ContactDavid Locke
CorrespondentDavid Locke
Acclarent Inc. 33 Technology Drive Irvine,  CA  92618
Product CodePGW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-03
Decision Date2020-01-30
Summary:summary

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