510(k) K042184 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
GOODKNIGHT H20, MODEL M-114600-00
| Applicant | Mallinckrodt Developpement France, Villers-Les-Nancy Cedex, FR |
| Decision | Substantially Equivalent, Jan 10, 2005 |
| Received | Aug 12, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042184
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.