K203155 is an FDA 510(k) clearance for the BreatheSuite MDI V1. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Breathesuite, Inc. (St. John'S, CA). The FDA issued a Cleared decision on September 17, 2021, 330 days after receiving the submission on October 22, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K203155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 2020 |
| Decision Date | September 17, 2021 |
| Days to Decision | 330 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAF - Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |