K243926 is an FDA 510(k) clearance for the Vivatmo pro-S. This device is classified as a System, Test, Breath Nitric Oxide (Class II - Special Controls, product code MXA).
Submitted by Bosch Healthcare Solutions GmbH (Waiblingen, DE). The FDA issued a Cleared decision on September 11, 2025, 265 days after receiving the submission on December 20, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3080.
| 510(k) Number | K243926 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2024 |
| Decision Date | September 11, 2025 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MXA - System, Test, Breath Nitric Oxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3080 |