K250624
- 510(k) number
- K250624
- Device name
- myAir
- Applicant
- Resmed Corp CA · US
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2025-05-28
- Date received
- 2025-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250624.pdf
Official FDA record: K250624
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.