510(k) K080966 ยท KPJ Chamber, Oxygen, Topical, Extremity
HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM
| Applicant | Aoti , Ltd., Galway, IE |
| Decision | Substantially Equivalent, Aug 6, 2008 |
| Received | Apr 4, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080966
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.