K220898 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. (Tonawanda, US). The FDA issued a Cleared decision on April 27, 2022, 30 days after receiving the submission on March 28, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5165.
| 510(k) Number | K220898 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2022 |
| Decision Date | April 27, 2022 |
| Days to Decision | 30 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 |