510(k) K250805 ยท CAW Generator, Oxygen, Portable
DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
| Applicant | Devilbiss Healthcare, LLC, Somerset PA, US |
| Decision | Substantially Equivalent, Dec 9, 2025 |
| Received | Mar 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250805
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.