510(k) K112489 ยท BZD Ventilator, Non-Continuous (Respirator)
SWIFT FX BELLA
| Applicant | Resmed, Ltd., Bella Vist Nsw, AU |
| Decision | Substantially Equivalent, Dec 7, 2011 |
| Received | Aug 29, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112489
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.