K222930
- 510(k) number
- K222930
- Device name
- Evolve Nitric Oxide Delivery System
- Applicant
- Mallinckrodt Manufacturing, LLC WI · US
- Product code
- MRN — Apparatus, Nitric Oxide Delivery
- Decision date
- 2023-12-06
- Date received
- 2022-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
510(k) Summary (official FDA PDF): K222930.pdf
Official FDA record: K222930
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.