510(k) K172648 ยท CAW Generator, Oxygen, Portable
Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
| Applicant | Devilbiss Healthcare, LLC, Somerset PA, US |
| Decision | Substantially Equivalent, Mar 23, 2018 |
| Received | Sep 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172648
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2022 | DeVilbiss Healthcare LLC 125 series iGO2 Portable Oxygen Concentrator-indicated for the
administration of supplemental oxygen.
Models: 125D, 125D-XB Open, Classified |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.