510(k) K080439 ยท BZD Ventilator, Non-Continuous (Respirator)
SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE
| Applicant | Mallinckrodt Developpement France, Boulder CO, US |
| Decision | Substantially Equivalent, May 16, 2008 |
| Received | Feb 19, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080439
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.