K253553
- 510(k) number
- K253553
- Device name
- Orion
- Applicant
- Resmed Corp CA · US
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2026-06-04
- Date received
- 2025-11-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K253553.pdf
Official FDA record: K253553
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.