K250805
- 510(k) number
- K250805
- Device name
- DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
- Applicant
- Devilbiss Healthcare, LLC PA · US
- Product code
- CAW — Generator, Oxygen, Portable
- Decision date
- 2025-12-09
- Date received
- 2025-03-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250805.pdf
Official FDA record: K250805
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.