K203695 is an FDA 510(k) clearance for the NObreath®. This device is classified as a System, Test, Breath Nitric Oxide (Class II - Special Controls, product code MXA).
Submitted by Bedfont Scientific, Ltd. (Maidstone, Kent, GB). The FDA issued a Cleared decision on December 17, 2021, 364 days after receiving the submission on December 18, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3080.
| 510(k) Number | K203695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2020 |
| Decision Date | December 17, 2021 |
| Days to Decision | 364 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 |