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.
| Device ID | K202180 |
| 510k Number | K202180 |
| Device Name: | Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001 |
| 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 | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-08-04 |
| Decision Date | 2020-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03664977030032 | K202180 | 000 |
| 03664977020033 | K202180 | 000 |
| 03664977010034 | K202180 | 000 |