The following data is part of a premarket notification filed by Trudell Medical International with the FDA for Aeroeclipse* One Ban.
| Device ID | K200063 |
| 510k Number | K200063 |
| Device Name: | AeroEclipse* ONE BAN |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Trudell Medical International 725 Baransway Drive London, CA N5v 5g4 |
| Contact | Marianne Tanton |
| Correspondent | Marianne Tanton Trudell Medical International 725 Baransway Drive London, CA N5v 5g4 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-13 |
| Decision Date | 2020-07-17 |