The following data is part of a premarket notification filed by Breathesuite Inc with the FDA for Breathesuite Mdi V1.
| Device ID | K203155 |
| 510k Number | K203155 |
| Device Name: | BreatheSuite MDI V1 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | BreatheSuite Inc 29 Rowan Street Unit 2 St. John's, CA A1b2x2 |
| Contact | Brett Vokey |
| Correspondent | Brett Vokey BreatheSuite Inc 29 Rowan Street Unit 2 St. John's, CA A1b2x2 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-22 |
| Decision Date | 2021-09-17 |