K253549
- 510(k) number
- K253549
- Device name
- DeVilbiss 5 Liter Oxygen Concentrator (555)
- Applicant
- Devilbiss Healthcare, LLC PA · US
- Product code
- CAW — Generator, Oxygen, Portable
- Decision date
- 2026-03-26
- Date received
- 2025-11-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253549.pdf
Official FDA record: K253549
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.