510(k) K083163 ยท CAW Generator, Oxygen, Portable
OMNI 2 OXYGEN SYSTEM
| Applicant | Sequal Technologies, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Oct 20, 2009 |
| Received | Oct 27, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083163
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2019 | Caire, Inc. SAROS Oxygen System Model 3000 Terminated |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.