The following data is part of a premarket notification filed by Trudell Medical International with the FDA for Aerochamber Plus* Flow-vu* Anti-static Valved Holding Chamber (vhc).
| Device ID | K181649 |
| 510k Number | K181649 |
| Device Name: | AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) |
| Classification | Holding Chambers, Direct Patient Interface |
| Applicant | Trudell Medical International 725 Third Street London, CA N5v 5g4 |
| Contact | Marianne Tanton |
| Correspondent | Marianne Tanton Trudell Medical International 725 Third Street London, CA N5v 5g4 |
| Product Code | NVP |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-22 |
| Decision Date | 2019-01-11 |
| Summary: | summary |