510(k) K041819 ยท BZD Ventilator, Non-Continuous (Respirator)
GOODKNIGHT 425, MODELM-114500-00
| Applicant | Mallinckrodt Developpement France, Pleasanton CA, US |
| Decision | Substantially Equivalent, Jul 22, 2004 |
| Received | Jul 6, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041819
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.