K242578
- 510(k) number
- K242578
- Device name
- EVOLVE Nitric Oxide Delivery System
- Applicant
- Mallinckrodt Manufacturing, LLC WI · US
- Product code
- MRN — Apparatus, Nitric Oxide Delivery
- Decision date
- 2025-01-03
- Date received
- 2024-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K242578.pdf
Official FDA record: K242578
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.