K234134
- 510(k) number
- K234134
- Device name
- AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System
- Applicant
- Resmed Pty Ltd (Registration Number: 3004604967) AU
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2024-09-24
- Date received
- 2023-12-29
- 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: K234134.pdf
Official FDA record: K234134
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.