Evolve Nitric Oxide Delivery System
Device Facts
| Record ID | K222930 |
|---|---|
| Device Name | Evolve Nitric Oxide Delivery System |
| Applicant | Mallinckrodt Manufacturing, LLC |
| Product Code | MRN · Anesthesiology |
| Decision Date | Dec 6, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5165 |
| Device Class | Class 2 |
Regulatory Classification
Identification
The nitric oxide administration apparatus is a device used to add nitric oxide to gases that are to be breathed by a patient. The nitric oxide administration apparatus is to be used in conjunction with a ventilator or other breathing gas administration system.
Special Controls
The special control for this device is FDA's “Guidance Document for Premarket Notification Submissions for Nitric Oxide Administration Apparatus, Nitric Oxide Analyzer, and Nitrogen Dioxide Analyzer.”
