510(k) K050359 ยท BZD Ventilator, Non-Continuous (Respirator)
ULTRA MIRAGE II MASK
| Applicant | Resmed, Ltd., Poway CA, US |
| Decision | Substantially Equivalent, Mar 16, 2005 |
| Received | Feb 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050359
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.