Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001

Bronchoscope (flexible Or Rigid)

Axess Vision Technology

The following data is part of a premarket notification filed by Axess Vision Technology with the FDA for Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001.

Pre-market Notification Details

Device IDK202180
510k NumberK202180
Device Name:Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001
ClassificationBronchoscope (flexible Or Rigid)
Applicant Axess Vision Technology Zone De La Liodière 6, Rue De La Flottière Joué-lès-tours,  FR 37300
ContactMarie-hélène Bacheley
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren,  NJ  07059
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2020-08-04
Decision Date2020-10-22

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.