510(k) K964078 ยท CAF Nebulizer (Direct Patient Interface)
3050 SPORT-NEB
| Applicant | Medical Industries America, Inc., Adel IA, US |
| Decision | Substantially Equivalent, Jan 10, 1997 |
| Received | Oct 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964078
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.