510(k) K974379 ยท CAF Nebulizer (Direct Patient Interface)
ULTRANEB
| Applicant | Bremed Italia, S.R.L., Arnold MO, US |
| Decision | Substantially Equivalent, Feb 18, 1998 |
| Received | Nov 20, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974379
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.