The following data is part of a premarket notification filed by Hemodia Sas with the FDA for Zeos Aqua Vision Pump And Tube.
| Device ID | K192921 |
| 510k Number | K192921 |
| Device Name: | Zeos Aqua Vision Pump And Tube |
| Classification | Arthroscope |
| Applicant | Hemodia SAS France Labege, FR 31670 |
| Contact | Adeline Theron |
| Correspondent | Arne Briest VISAMED GmbH Kastellstr. 8 Karlsruhe, DE 76227 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-16 |
| Decision Date | 2020-10-09 |