510(k) K202180— Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001

Substantially Equivalent

Axess Vision Technology

Clearance details

Applicant: Axess Vision Technology
Product code: Code EOQ
Advisory panel: Ear, Nose, Throat
Date received: 2020-08-04
Decision date: 2020-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Joué-Lès-Tours, FR

Adverse events under product code EOQ

product code EOQ

Death: 135
Injury: 2,863
Malfunction: 21,662
Total: 24,660

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.