The following data is part of a premarket notification filed by Axess Vision Technology with the FDA for Broncoflex Agile, Broncoflex Vortex, Screeni.
| Device ID | K212886 |
| 510k Number | K212886 |
| Device Name: | Broncoflex Agile, Broncoflex Vortex, Screeni |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Axess Vision Technology Zone De La Liodière 6, Rue De La Flottière Joué-lès-tours, FR 37300 |
| Contact | Marie-hélène Bacheley |
| Correspondent | Marie-hélène Bacheley Axess Vision Technology Zone De La Liodière 6, Rue De La Flottière Joué-lès-tours, FR 37300 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-10 |
| Decision Date | 2022-02-16 |