K240410 is an FDA 510(k) clearance for the EVOLVE Nitric Oxide Delivery System. This device is classified as a Apparatus, Nitric Oxide Delivery (Class II - Special Controls, product code MRN).
Submitted by Malinckrodt Manufacturing, LLC (Madison, US). The FDA issued a Cleared decision on May 28, 2024, 106 days after receiving the submission on February 12, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5165.
| 510(k) Number | K240410 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2024 |
| Decision Date | May 28, 2024 |
| Days to Decision | 106 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 |