510(k) K081321 ยท BZD Ventilator, Non-Continuous (Respirator)
MODIFICATION TO MIRAGE MICRO
| Applicant | Resmed, Ltd., Poway CA, US |
| Decision | Substantially Equivalent, Oct 9, 2008 |
| Received | May 12, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081321
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.