510(k) K080516 ยท BZD Ventilator, Non-Continuous (Respirator)
LAMIN AIR
| Applicant | Remgenic, LLC, Bonita Springs FL, US |
| Decision | Substantially Equivalent, Jun 23, 2008 |
| Received | Feb 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080516
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.