510(k) K082209 ยท BZD Ventilator, Non-Continuous (Respirator)
DEVILBISS DV5M SMARTLINK SYSTEM
| Applicant | Sunrise Medical, Somerset PA, US |
| Decision | Substantially Equivalent, Oct 28, 2008 |
| Received | Aug 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082209
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.