510(k) K083816 ยท BZD Ventilator, Non-Continuous (Respirator)
RES TRAXX ONLINE, MODEL: R14
| Applicant | Resmed, Ltd., Poway CA, US |
| Decision | Substantially Equivalent, Mar 20, 2009 |
| Received | Dec 22, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083816
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.