K251661
- 510(k) number
- K251661
- Device name
- Mariana Minerva; Mariana Nimbus
- Applicant
- Resmed Pty , Ltd. AU
- Product code
- MNS — Ventilator, Continuous, Non-Life-Supporting
- Decision date
- 2026-02-23
- Date received
- 2025-05-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K251661.pdf
Official FDA record: K251661
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.