510(k) K053240 ยท CAW Generator, Oxygen, Portable
DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES
| Applicant | Sunrise Medical, Somerset PA, US |
| Decision | Substantially Equivalent, Feb 3, 2006 |
| Received | Nov 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053240
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2006 | Sunrise Medical DeVilbiss iFill Personal Oxygen Station model number 535D. Terminated |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.