K230476
- 510(k) number
- K230476
- Device name
- Oran Park Mask
- Applicant
- Resmed Pty Ltd (Registration Number: 3004604967) AU
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2023-10-19
- Date received
- 2023-02-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K230476.pdf
Official FDA record: K230476
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.