K231823 is an FDA 510(k) clearance for the NOxBOXi Nitric Oxide Delivery System. This device is classified as a Apparatus, Nitric Oxide Delivery (Class II - Special Controls, product code MRN).
Submitted by Linde Gas & Equipment, Inc. (Livingston, US). The FDA issued a Cleared decision on August 11, 2023, 51 days after receiving the submission on June 21, 2023.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5165.
| 510(k) Number | K231823 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2023 |
| Decision Date | August 11, 2023 |
| Days to Decision | 51 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | MRN - Apparatus, Nitric Oxide Delivery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5165 |