K240410
- 510(k) number
- K240410
- Device name
- EVOLVE Nitric Oxide Delivery System
- Applicant
- Malinckrodt Manufacturing, LLC WI · US
- Product code
- MRN — Apparatus, Nitric Oxide Delivery
- Decision date
- 2024-05-28
- Date received
- 2024-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K240410.pdf
Official FDA record: K240410
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.