510(k) K991722 ยท CAW Generator, Oxygen, Portable
DEVILBISS 5 LITER OXYGEN CONCENTRATOR
| Applicant | Sunrise Medical Hhg, Inc., Somerset PA, US |
| Decision | Substantially Equivalent, Nov 3, 1999 |
| Received | May 20, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991722
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 30, 2008 | Sunrise Medical DeVilbiss Model 515A Oxygen Concentrator
Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities. Terminated |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.