Submission Details
| 510(k) Number | K240410 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
EVOLVE Nitric Oxide Delivery System
May 2024
Decision
106d
Days
Class 2
Risk
About This 510(k) Submission
K240410 is an FDA 510(k) clearance for the EVOLVE Nitric Oxide Delivery System, 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 review panel. Regulated under 21 CFR 868.5165.
Device Classification
| Product Code | MRN — Apparatus, Nitric Oxide Delivery |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5165 |
Manufacturer
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