510(k) K970542 ยท CAF Nebulizer (Direct Patient Interface)
MASTER NEB II
| Applicant | Bremed Italia, S.R.L., Arnold MO, US |
| Decision | Substantially Equivalent, Jun 24, 1997 |
| Received | Feb 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970542
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.