K241216
- 510(k) number
- K241216
- Device name
- myAir
- Applicant
- Resmed Corp CA · US
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2024-09-26
- Date received
- 2024-05-01
- 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: K241216.pdf
Official FDA record: K241216
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.