510(k) K013931 ยท CAW Generator, Oxygen, Portable
OMNI OXYGEN SYSTEM, MODEL 1000
| Applicant | Sequal Technologies, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 27, 2002 |
| Received | Nov 28, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013931
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2009 | Sequal Technologies Inc SeQual Technologies Inc. Eclipse Oxygen System, Model 1000
Indicated for the administration of supplemental oxygen. Terminated |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.