510(k) K113780 ยท BZD Ventilator, Non-Continuous (Respirator)
EASYCARE TX SYSTEM (CONNEXUNS)
| Applicant | Resmed, Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, Apr 20, 2012 |
| Received | Dec 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113780
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.