510(k) K052396 ยท CAW Generator, Oxygen, Portable
OXYSURE PORTABLE OXYGEN GENERATOR, MODEL 615
| Applicant | Oxysure Systems, Inc., Frisco TX, US |
| Decision | Substantially Equivalent, Dec 9, 2005 |
| Received | Aug 31, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052396
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2015 | Oxysure Systems, Inc. OxySure Model 615 disposable replacement cartridges, for portable oxygen generator. Terminated |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.